Manufacturer registered with FDA

Eclectic Co., Ltd.

Hwaseong-si, South Korea. Lists 3 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10091703Manufacturer1 clearance in five years

Device types listed: 3
Brands and models: 937
510(k) clearances: 12024–2024
Markets registered in: 1United States
Establishments: 1South Korea

510(k) clearances per year, 2007–2026

Devices listed with FDA

What Eclectic Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Endosseous Dental Implant AbutmentNHA · Class 2	Implant abutments	Maker	PreXolid Abutment Screw 2.10mm Hex1.20mm ASMRPreXolid Abutment Screw 2.10mm Hex1.23mm ASPMPreXolid Abutment Screw 2.10mm Hex1.74mm ASSRPreXolid Abutment Screw 2.20mm Hex1.74mm ASSMPreXolid Abutment Screw 2.30mm Hex1.20mm ASASPreXolid Abutment Screw 2.30mm Hex1.23mm ASPRPreXolid Abutment Screw 2.30mm Hex1.27mm ASDSPreXolid Angled Abutment 4.50mm H80mm GH0.80mm, AAM 17451APreXolid Angled Abutment 4.50mm H80mm GH0.80mm, AAR 17451APreXolid Angled Abutment 4.50mm H80mm GH1.80mm, AAM 17452A 357 more PreXolid Angled Abutment 4.50mm H80mm GH1.80mm, AAR 17452APreXolid Angled Abutment 4.50mm H80mm GH2.80mm, AAM 17453APreXolid Angled Abutment 4.50mm H80mm GH2.80mm, AAR 17453APreXolid Angled Abutment 4.50mm H80mm GH3.80mm, AAM 17454APreXolid Angled Abutment 4.50mm H80mm GH3.80mm, AAR 17454APreXolid Angled Abutment 40mm H80mm GH0.80mm, AAM 17401APreXolid Angled Abutment 40mm H80mm GH0.80mm, AAR 17401APreXolid Angled Abutment 40mm H80mm GH1.80mm, AAM 17402APreXolid Angled Abutment 40mm H80mm GH1.80mm, AAR 17402APreXolid Angled Abutment 40mm H80mm GH2.80mm, AAM 17403APreXolid Angled Abutment 40mm H80mm GH2.80mm, AAR 17403APreXolid Angled Abutment 40mm H80mm GH3.80mm, AAM 17404APreXolid Angled Abutment 40mm H80mm GH3.80mm, AAR 17404APreXolid Angled Abutment 50mm H80mm GH0.80mm, AAR 17501APreXolid Angled Abutment 50mm H80mm GH1.80mm, AAR 17502APreXolid Angled Abutment 50mm H80mm GH2.80mm, AAR 17503APreXolid Angled Abutment 50mm H80mm GH3.80mm, AAR 17504APreXolid Angled Abutment 60mm H80mm GH0.80mm, AAR 17601APreXolid Angled Abutment 60mm H80mm GH1.80mm, AAR 17602APreXolid Angled Abutment 60mm H80mm GH2.80mm, AAR 17603APreXolid Angled Abutment 60mm H80mm GH3.80mm, AAR 17604APreXolid CAD/CAM Abutment 100mm P1MRXPreXolid CAD/CAM Abutment 100mm P1MRXMPreXolid CAD/CAM Abutment 100mm P1MRXNPreXolid CAD/CAM Abutment 140mm P4MRXPreXolid CAD/CAM Abutment 140mm P4MRXMPreXolid CAD/CAM Abutment 140mm P4MRXNPreXolid Cover Screw 3.20mm CS 32PreXolid Cover Screw 3.75mm CS 37PreXolid Cover Screw 4.30mm CS 43PreXolid Healing Abutment 4.30mm GH30mm L7.50mm, HAM 433PreXolid Healing Abutment 4.30mm GH30mm L8.50mm, HAR 433PreXolid Healing Abutment 4.30mm GH40mm L8.50mm, HAM 434PreXolid Healing Abutment 4.30mm GH40mm L9.50mm, HAR 434PreXolid Healing Abutment 4.30mm GH50mm L10.50mm, HAR 435PreXolid Healing Abutment 4.30mm GH50mm L9.50mm, HAM 435PreXolid Healing Abutment 4.30mm GH60mm L10.50mm, HAM 436PreXolid Healing Abutment 4.30mm GH60mm L11.50mm, HAR 436PreXolid Healing Abutment 4.30mm GH70mm L11.50mm, HAM 437PreXolid Healing Abutment 4.30mm GH70mm L12.50mm, HAR 437PreXolid Healing Abutment 4.30mm GH80mm L12.50mm, HAM 438PreXolid Healing Abutment 4.30mm GH80mm L13.50mm, HAR 438PreXolid Healing Abutment 4.30mm GH90mm L13.50mm, HAM 439PreXolid Healing Abutment 4.30mm GH90mm L14.50mm, HAR 439PreXolid Healing Abutment 4.80mm GH30mm L7.50mm, HAM 483PreXolid Healing Abutment 4.80mm GH30mm L8.50mm, HAR 483PreXolid Healing Abutment 4.80mm GH40mm L8.50mm, HAM 484PreXolid Healing Abutment 4.80mm GH40mm L9.50mm, HAR 484PreXolid Healing Abutment 4.80mm GH50mm L10.50mm, HAR 485PreXolid Healing Abutment 4.80mm GH50mm L9.50mm, HAM 485PreXolid Healing Abutment 4.80mm GH60mm L10.50mm, HAM 486PreXolid Healing Abutment 4.80mm GH60mm L11.50mm, HAR 486PreXolid Healing Abutment 4.80mm GH70mm L11.50mm, HAM 487PreXolid Healing Abutment 4.80mm GH70mm L12.50mm, HAR 487PreXolid Healing Abutment 4.80mm GH80mm L12.50mm, HAM 488PreXolid Healing Abutment 4.80mm GH80mm L13.50mm, HAR 488PreXolid Healing Abutment 4.80mm GH90mm L13.50mm, HAM 489PreXolid Healing Abutment 4.80mm GH90mm L14.50mm, HAR 489PreXolid Healing Abutment 5.30mm GH30mm L8.50mm, HAR 533PreXolid Healing Abutment 5.30mm GH40mm L9.50mm, HAR 534PreXolid Healing Abutment 5.30mm GH50mm L10.50mm, HAR 535PreXolid Healing Abutment 5.30mm GH60mm L11.50mm, HAR 536PreXolid Healing Abutment 5.30mm GH70mm L12.50mm, HAR 537PreXolid Healing Abutment 5.30mm GH80mm L13.50mm, HAR 538PreXolid Healing Abutment 5.30mm GH90mm L14.50mm, HAR 539PreXolid Healing Abutment 5.80mm GH30mm L8.50mm, HAR 583PreXolid Healing Abutment 5.80mm GH40mm L9.50mm, HAR 584PreXolid Healing Abutment 5.80mm GH50mm L10.50mm, HAR 585PreXolid Healing Abutment 5.80mm GH60mm L11.50mm, HAR 586PreXolid Healing Abutment 5.80mm GH70mm L12.50mm, HAR 587PreXolid Healing Abutment 5.80mm GH80mm L13.50mm, HAR 588PreXolid Healing Abutment 5.80mm GH90mm L14.50mm, HAR 589PreXolid Healing Abutment 6.30mm GH30mm L8.50mm, HAR 633PreXolid Healing Abutment 6.30mm GH40mm L9.50mm, HAR 634PreXolid Healing Abutment 6.30mm GH50mm L10.50mm, HAR 635PreXolid Healing Abutment 6.30mm GH60mm L11.50mm, HAR 636PreXolid Healing Abutment 6.30mm GH70mm L12.50mm, HAR 637PreXolid Healing Abutment 6.30mm GH80mm L13.50mm, HAR 638PreXolid Healing Abutment 6.30mm GH90mm L14.50mm, HAR 639PreXolid Healing Abutment 6.80mm GH30mm L8.50mm, HAR 683PreXolid Healing Abutment 6.80mm GH40mm L9.50mm, HAR 684PreXolid Healing Abutment 6.80mm GH50mm L10.50mm, HAR 685PreXolid Healing Abutment 6.80mm GH60mm L11.50mm, HAR 686PreXolid Healing Abutment 6.80mm GH70mm L12.50mm, HAR 687PreXolid Healing Abutment 6.80mm GH80mm L13.50mm, HAR 688PreXolid Healing Abutment 6.80mm GH90mm L14.50mm, HAR 689PreXolid Healing Abutment 7.30mm GH30mm L8.50mm, HAR 733PreXolid Healing Abutment 7.30mm GH40mm L9.50mm, HAR 734PreXolid Healing Abutment 7.30mm GH50mm L10.50mm, HAR 735PreXolid Healing Abutment 7.30mm GH60mm L11.50mm, HAR 736PreXolid Healing Abutment 7.30mm GH70mm L12.50mm, HAR 737PreXolid Healing Abutment 7.30mm GH80mm L13.50mm, HAR 738PreXolid Healing Abutment 7.30mm GH90mm L14.50mm, HAR 739PreXolid Healing Abutment 8.30mm GH30mm L8.50mm, HAR 833PreXolid Healing Abutment 8.30mm GH40mm L9.50mm, HAR 834PreXolid Healing Abutment 8.30mm GH50mm L10.50mm, HAR 835PreXolid Healing Abutment 8.30mm GH60mm L11.50mm, HAR 836PreXolid Healing Abutment 8.30mm GH70mm L12.50mm, HAR 837PreXolid Healing Abutment 8.30mm GH80mm L13.50mm, HAR 838PreXolid Healing Abutment 8.30mm GH90mm L14.50mm, HAR 839PreXolid Implant 3.75mm L100 FSM 3710PreXolid Implant 3.75mm L11.50 FSM 3711PreXolid Implant 3.75mm L130 FSM 3713PreXolid Implant 3.75mm L8.50 FSM 3708PreXolid Implant 4.25mm L100 FSR 4210PreXolid Implant 4.25mm L11.50 FSR 4211PreXolid Implant 4.25mm L130 FSR 4213PreXolid Implant 4.25mm L7.80 FSR 4207PreXolid Implant 4.25mm L8.50 FSR 4208PreXolid Implant 4.60mm L100 FSR 4610PreXolid Implant 4.60mm L11.50 FSR 4611PreXolid Implant 4.60mm L130 FSR 4613PreXolid Implant 4.60mm L7.80 FSR 4607PreXolid Implant 4.60mm L8.50 FSR 4608PreXolid Implant 5.60mm L100 FSR 5610PreXolid Implant 5.60mm L11.50 FSR 5611PreXolid Implant 5.60mm L130 FSR 5613PreXolid Implant 5.60mm L7.80 FSR 5607PreXolid Implant 5.60mm L8.50 FSR 5608PreXolid Implant 55mm L100 FSR 5010PreXolid Implant 55mm L11.50 FSR 5011PreXolid Implant 55mm L130 FSR 5013PreXolid Implant 55mm L7.80 FSR 5007PreXolid Implant 55mm L8.50 FSR 5008PreXolid Implant 6.20mm L100 FSR 6210PreXolid Implant 6.20mm L11.50 FSR 6211PreXolid Implant 6.20mm L130 FSR 6213PreXolid Implant 6.20mm L7.80 FSR 6207PreXolid Implant 6.20mm L8.50 FSR 6208PreXolid Implant 7.10mm L100 FSR 7110PreXolid Implant 7.10mm L11.50 FSR 7111PreXolid Implant 7.10mm L130 FSR 7113PreXolid Implant 7.10mm L7.80 FSR 7107PreXolid Implant 7.10mm L8.50 FSR 7108PreXolid Locator Abutment 3.87mm GH0.84mm, LTM 3810PreXolid Locator Abutment 3.87mm GH1.84mm, LTM 3820PreXolid Locator Abutment 3.87mm GH2.84mm, LTM 3830PreXolid Locator Abutment 3.87mm GH3.84mm, LTM 3840PreXolid Locator Abutment 3.87mm GH4.84mm, LTM 3850PreXolid Locator Abutment 3.87mm GH5.84mm, LTM 3860	2024
Root-Form Endosseous ImplantDZE · Class 2	Dental implants	Maker	PreXolid Angled Abutment 4.50mm H80mm GH0.80mm, AAM 17451APreXolid Angled Abutment 4.50mm H80mm GH0.80mm, AAR 17451APreXolid Angled Abutment 4.50mm H80mm GH1.80mm, AAM 17452APreXolid Angled Abutment 4.50mm H80mm GH1.80mm, AAR 17452APreXolid Angled Abutment 4.50mm H80mm GH2.80mm, AAM 17453APreXolid Angled Abutment 4.50mm H80mm GH2.80mm, AAR 17453APreXolid Angled Abutment 4.50mm H80mm GH3.80mm, AAM 17454APreXolid Angled Abutment 4.50mm H80mm GH3.80mm, AAR 17454APreXolid Angled Abutment 40mm H80mm GH0.80mm, AAM 17401APreXolid Angled Abutment 40mm H80mm GH0.80mm, AAR 17401A 344 more PreXolid Angled Abutment 40mm H80mm GH1.80mm, AAM 17402APreXolid Angled Abutment 40mm H80mm GH1.80mm, AAR 17402APreXolid Angled Abutment 40mm H80mm GH2.80mm, AAM 17403APreXolid Angled Abutment 40mm H80mm GH2.80mm, AAR 17403APreXolid Angled Abutment 40mm H80mm GH3.80mm, AAM 17404APreXolid Angled Abutment 40mm H80mm GH3.80mm, AAR 17404APreXolid Angled Abutment 50mm H80mm GH0.80mm, AAR 17501APreXolid Angled Abutment 50mm H80mm GH1.80mm, AAR 17502APreXolid Angled Abutment 50mm H80mm GH2.80mm, AAR 17503APreXolid Angled Abutment 50mm H80mm GH3.80mm, AAR 17504APreXolid Angled Abutment 60mm H80mm GH0.80mm, AAR 17601APreXolid Angled Abutment 60mm H80mm GH1.80mm, AAR 17602APreXolid Angled Abutment 60mm H80mm GH2.80mm, AAR 17603APreXolid Angled Abutment 60mm H80mm GH3.80mm, AAR 17604APreXolid Cover Screw 3.20mm CS 32PreXolid Cover Screw 3.75mm CS 37PreXolid Cover Screw 4.30mm CS 43PreXolid Healing Abutment 4.30mm GH30mm L7.50mm, HAM 433PreXolid Healing Abutment 4.30mm GH30mm L8.50mm, HAR 433PreXolid Healing Abutment 4.30mm GH40mm L8.50mm, HAM 434PreXolid Healing Abutment 4.30mm GH40mm L9.50mm, HAR 434PreXolid Healing Abutment 4.30mm GH50mm L10.50mm, HAR 435PreXolid Healing Abutment 4.30mm GH50mm L9.50mm, HAM 435PreXolid Healing Abutment 4.30mm GH60mm L10.50mm, HAM 436PreXolid Healing Abutment 4.30mm GH60mm L11.50mm, HAR 436PreXolid Healing Abutment 4.30mm GH70mm L11.50mm, HAM 437PreXolid Healing Abutment 4.30mm GH70mm L12.50mm, HAR 437PreXolid Healing Abutment 4.30mm GH80mm L12.50mm, HAM 438PreXolid Healing Abutment 4.30mm GH80mm L13.50mm, HAR 438PreXolid Healing Abutment 4.30mm GH90mm L13.50mm, HAM 439PreXolid Healing Abutment 4.30mm GH90mm L14.50mm, HAR 439PreXolid Healing Abutment 4.80mm GH30mm L7.50mm, HAM 483PreXolid Healing Abutment 4.80mm GH30mm L8.50mm, HAR 483PreXolid Healing Abutment 4.80mm GH40mm L8.50mm, HAM 484PreXolid Healing Abutment 4.80mm GH40mm L9.50mm, HAR 484PreXolid Healing Abutment 4.80mm GH50mm L10.50mm, HAR 485PreXolid Healing Abutment 4.80mm GH50mm L9.50mm, HAM 485PreXolid Healing Abutment 4.80mm GH60mm L10.50mm, HAM 486PreXolid Healing Abutment 4.80mm GH60mm L11.50mm, HAR 486PreXolid Healing Abutment 4.80mm GH70mm L11.50mm, HAM 487PreXolid Healing Abutment 4.80mm GH70mm L12.50mm, HAR 487PreXolid Healing Abutment 4.80mm GH80mm L12.50mm, HAM 488PreXolid Healing Abutment 4.80mm GH80mm L13.50mm, HAR 488PreXolid Healing Abutment 4.80mm GH90mm L13.50mm, HAM 489PreXolid Healing Abutment 4.80mm GH90mm L14.50mm, HAR 489PreXolid Healing Abutment 5.30mm GH30mm L8.50mm, HAR 533PreXolid Healing Abutment 5.30mm GH40mm L9.50mm, HAR 534PreXolid Healing Abutment 5.30mm GH50mm L10.50mm, HAR 535PreXolid Healing Abutment 5.30mm GH60mm L11.50mm, HAR 536PreXolid Healing Abutment 5.30mm GH70mm L12.50mm, HAR 537PreXolid Healing Abutment 5.30mm GH80mm L13.50mm, HAR 538PreXolid Healing Abutment 5.30mm GH90mm L14.50mm, HAR 539PreXolid Healing Abutment 5.80mm GH30mm L8.50mm, HAR 583PreXolid Healing Abutment 5.80mm GH40mm L9.50mm, HAR 584PreXolid Healing Abutment 5.80mm GH50mm L10.50mm, HAR 585PreXolid Healing Abutment 5.80mm GH60mm L11.50mm, HAR 586PreXolid Healing Abutment 5.80mm GH70mm L12.50mm, HAR 587PreXolid Healing Abutment 5.80mm GH80mm L13.50mm, HAR 588PreXolid Healing Abutment 5.80mm GH90mm L14.50mm, HAR 589PreXolid Healing Abutment 6.30mm GH30mm L8.50mm, HAR 633PreXolid Healing Abutment 6.30mm GH40mm L9.50mm, HAR 634PreXolid Healing Abutment 6.30mm GH50mm L10.50mm, HAR 635PreXolid Healing Abutment 6.30mm GH60mm L11.50mm, HAR 636PreXolid Healing Abutment 6.30mm GH70mm L12.50mm, HAR 637PreXolid Healing Abutment 6.30mm GH80mm L13.50mm, HAR 638PreXolid Healing Abutment 6.30mm GH90mm L14.50mm, HAR 639PreXolid Healing Abutment 6.80mm GH30mm L8.50mm, HAR 683PreXolid Healing Abutment 6.80mm GH40mm L9.50mm, HAR 684PreXolid Healing Abutment 6.80mm GH50mm L10.50mm, HAR 685PreXolid Healing Abutment 6.80mm GH60mm L11.50mm, HAR 686PreXolid Healing Abutment 6.80mm GH70mm L12.50mm, HAR 687PreXolid Healing Abutment 6.80mm GH80mm L13.50mm, HAR 688PreXolid Healing Abutment 6.80mm GH90mm L14.50mm, HAR 689PreXolid Healing Abutment 7.30mm GH30mm L8.50mm, HAR 733PreXolid Healing Abutment 7.30mm GH40mm L9.50mm, HAR 734PreXolid Healing Abutment 7.30mm GH50mm L10.50mm, HAR 735PreXolid Healing Abutment 7.30mm GH60mm L11.50mm, HAR 736PreXolid Healing Abutment 7.30mm GH70mm L12.50mm, HAR 737PreXolid Healing Abutment 7.30mm GH80mm L13.50mm, HAR 738PreXolid Healing Abutment 7.30mm GH90mm L14.50mm, HAR 739PreXolid Healing Abutment 8.30mm GH30mm L8.50mm, HAR 833PreXolid Healing Abutment 8.30mm GH40mm L9.50mm, HAR 834PreXolid Healing Abutment 8.30mm GH50mm L10.50mm, HAR 835PreXolid Healing Abutment 8.30mm GH60mm L11.50mm, HAR 836PreXolid Healing Abutment 8.30mm GH70mm L12.50mm, HAR 837PreXolid Healing Abutment 8.30mm GH80mm L13.50mm, HAR 838PreXolid Healing Abutment 8.30mm GH90mm L14.50mm, HAR 839PreXolid Implant 3.75mm L100 FSM 3710PreXolid Implant 3.75mm L11.50 FSM 3711PreXolid Implant 3.75mm L130 FSM 3713PreXolid Implant 3.75mm L8.50 FSM 3708PreXolid Implant 4.25mm L100 FSR 4210PreXolid Implant 4.25mm L11.50 FSR 4211PreXolid Implant 4.25mm L130 FSR 4213PreXolid Implant 4.25mm L7.80 FSR 4207PreXolid Implant 4.25mm L8.50 FSR 4208PreXolid Implant 4.60mm L100 FSR 4610PreXolid Implant 4.60mm L11.50 FSR 4611PreXolid Implant 4.60mm L130 FSR 4613PreXolid Implant 4.60mm L7.80 FSR 4607PreXolid Implant 4.60mm L8.50 FSR 4608PreXolid Implant 5.60mm L100 FSR 5610PreXolid Implant 5.60mm L11.50 FSR 5611PreXolid Implant 5.60mm L130 FSR 5613PreXolid Implant 5.60mm L7.80 FSR 5607PreXolid Implant 5.60mm L8.50 FSR 5608PreXolid Implant 55mm L100 FSR 5010PreXolid Implant 55mm L11.50 FSR 5011PreXolid Implant 55mm L130 FSR 5013PreXolid Implant 55mm L7.80 FSR 5007PreXolid Implant 55mm L8.50 FSR 5008PreXolid Implant 6.20mm L100 FSR 6210PreXolid Implant 6.20mm L11.50 FSR 6211PreXolid Implant 6.20mm L130 FSR 6213PreXolid Implant 6.20mm L7.80 FSR 6207PreXolid Implant 6.20mm L8.50 FSR 6208PreXolid Implant 7.10mm L100 FSR 7110PreXolid Implant 7.10mm L11.50 FSR 7111PreXolid Implant 7.10mm L130 FSR 7113PreXolid Implant 7.10mm L7.80 FSR 7107PreXolid Implant 7.10mm L8.50 FSR 7108PreXolid Locator Abutment 3.87mm GH0.84mm, LTM 3810PreXolid Locator Abutment 3.87mm GH1.84mm, LTM 3820PreXolid Locator Abutment 3.87mm GH2.84mm, LTM 3830PreXolid Locator Abutment 3.87mm GH3.84mm, LTM 3840PreXolid Locator Abutment 3.87mm GH4.84mm, LTM 3850PreXolid Locator Abutment 3.87mm GH5.84mm, LTM 3860PreXolid Locator Abutment 4.87mm GH16mm, LTR 4810PreXolid Locator Abutment 4.87mm GH26mm, LTR 4820PreXolid Locator Abutment 4.87mm GH36mm, LTR 4830PreXolid Locator Abutment 4.87mm GH46mm, LTR 4840PreXolid Locator Abutment 4.87mm GH56mm, LTR 4850PreXolid Locator Abutment 4.87mm GH66mm, LTR 4860PreXolid Multi-Unit 40mm H6.30 MCT 40HPreXolid Multi-Unit 40mm H6.30 MCT 40NPreXolid Multi-Unit 50mm H7.30 MCT 50HPreXolid Multi-Unit 50mm H7.30 MCT 50NPreXolid Transfer Abutment 4.60mm H40mm GH0.80mm, CAM 46401PreXolid Transfer Abutment 4.60mm H40mm GH0.80mm, CAR 46401PreXolid Transfer Abutment 4.60mm H40mm GH1.80mm, CAM 46402	2024
Endosseous Dental Implant AccessoriesNDP · Class 1	Implant instruments & surgical kits	Maker	Anchor Drill 1.35mm ACD 13Bone Expander 2.80mm BEX 28Bone Expander 3.40mm BEX 34Bone Expander 3.90mm BEX 39Bone Expander 4.30mm BEX 43Bone Profile Drill 4.60mm GBD 46Bone Profile Drill 50mm Wide Sleeve GBD 50WCortical Drill 4.25mm CTD 42Cortical Drill 4.60mm CTD 46Cortical Drill 55mm CTD 50 206 more Depth Gauge and Probe DGPDirection Indicator 2.80mm DIN 32Direction Indicator 3.20mm DIN 37Direction Indicator 3.60mm DIN 42Direction Indicator 4.50mm DIN 50Direction Indicator 40mm DIN 46Drill Extension DEXFixture Driver Machine L280mm FHM SFixture Driver Machine L280mm FHR SFixture Driver Machine L340mm FHM LFixture Driver Machine L340mm FHR LFixture Driver Ratchet L18.50mm FRM SFixture Driver Ratchet L18.50mm FRR SFixture Driver Ratchet L25.50mm FRM LFixture Driver Ratchet L25.50mm FRR LFixture Tapping Remover 2.40mm L230mm FTR 24SFixture Tapping Remover 2.40mm L290mm FTR 24LFixture Tapping Remover 2.80mm L230mm FTR 28SFixture Tapping Remover 2.80mm L280mm FTR 28LGingival Height Measure GHMGuide Cortical Drill 4.60mm L100mm GCD 4610Guide Cortical Drill 4.60mm L130mm GCD 4613Guide Cortical Drill 4.60mm L70mm GCD 4607Guide Cortical Drill 55mm L100mm Wide Sleeve GCD 5010WGuide Cortical Drill 55mm L130mm Wide Sleeve GCD 5013WGuide Cortical Drill 55mm L70mm Wide Sleeve GCD 5007WGuide Drill 20mm L33.50mm GLDGuide Fixture Driver Machine L310mm GFH EGuide Fixture Driver Machine L310mm GFH MGuide Fixture Driver Machine L310mm GFH RGuide Fixture Driver Ratchet L300mm GFR EGuide Fixture Driver Ratchet L300mm GFR MGuide Fixture Driver Ratchet L300mm GFR RGuide Sleeve 3.70mm GSL 37NGuide Sleeve 5.70mm GSL 57WGuide Sleeve 50mm GSL 50RGuide Taper Drill 3.20mm L100mm GTD 3710Guide Taper Drill 3.20mm L100mm Wide Sleeve GTD 3710WGuide Taper Drill 3.20mm L11.50mm GTD 3711Guide Taper Drill 3.20mm L11.50mm Wide Sleeve GTD 3711WGuide Taper Drill 3.20mm L130mm GTD 3713Guide Taper Drill 3.20mm L130mm Wide Sleeve GTD 3713WGuide Taper Drill 3.20mm L60mm GTD 3706Guide Taper Drill 3.20mm L60mm Wide Sleeve GTD 3706WGuide Taper Drill 3.20mm L70mm GTD 3707Guide Taper Drill 3.20mm L70mm Wide Sleeve GTD 3707WGuide Taper Drill 3.20mm L8.50mm GTD 3708Guide Taper Drill 3.20mm L8.50mm Wide Sleeve GTD 3708WGuide Taper Drill 3.60mm L100mm GTD 4210Guide Taper Drill 3.60mm L100mm Wide Sleeve GTD 4210WGuide Taper Drill 3.60mm L11.50mm GTD 4211Guide Taper Drill 3.60mm L11.50mm Wide Sleeve GTD 4211WGuide Taper Drill 3.60mm L130mm GTD 4213Guide Taper Drill 3.60mm L130mm Wide Sleeve GTD 4213WGuide Taper Drill 3.60mm L60mm GTD 4206Guide Taper Drill 3.60mm L60mm Wide Sleeve GTD 4206WGuide Taper Drill 3.60mm L70mm GTD 4207Guide Taper Drill 3.60mm L70mm Wide Sleeve GTD 4207WGuide Taper Drill 3.60mm L8.50mm GTD 4208Guide Taper Drill 3.60mm L8.50mm Wide Sleeve GTD 4208WGuide Taper Drill 4.50mm L100mm Wide Sleeve GTD 5010WGuide Taper Drill 4.50mm L11.50mm Wide Sleeve GTD 5011WGuide Taper Drill 4.50mm L130mm Wide Sleeve GTD 5013WGuide Taper Drill 4.50mm L60mm Wide Sleeve GTD 5006WGuide Taper Drill 4.50mm L70mm Wide Sleeve GTD 5007WGuide Taper Drill 4.50mm L8.50mm Wide Sleeve GTD 5008WGuide Taper Drill 40mm L100mm GTD 4610Guide Taper Drill 40mm L100mm Wide Sleeve GTD 4610WGuide Taper Drill 40mm L11.50mm GTD 4611Guide Taper Drill 40mm L11.50mm Wide Sleeve GTD 4611WGuide Taper Drill 40mm L130mm GTD 4613Guide Taper Drill 40mm L130mm Wide Sleeve GTD 4613WGuide Taper Drill 40mm L60mm GTD 4606Guide Taper Drill 40mm L60mm Wide Sleeve GTD 4606WGuide Taper Drill 40mm L70mm GTD 4607Guide Taper Drill 40mm L70mm Wide Sleeve GTD 4607WGuide Taper Drill 40mm L8.50mm GTD 4608Guide Taper Drill 40mm L8.50mm Wide Sleeve GTD 4608WGuide Twist Drill 2.80mm L100mm GTWD 2810Guide Twist Drill 2.80mm L11.50mm GTWD 2811Guide Twist Drill 2.80mm L130mm GTWD 2813Guide Twist Drill 2.80mm L60mm GTWD 2806Guide Twist Drill 2.80mm L70mm GTWD 2807Guide Twist Drill 2.80mm L80mm GTWD 2808Multi-Unit Abutment Driver MUDPath Correction Drill 2.45mm L130mm GPCD 2513Path Correction Drill 2.45mm L130mm Wide Sleeve GPCD 2513WPath Correction Drill 2.45mm L70mm GPCD 2507Path Correction Drill 2.45mm L70mm Wide Sleeve GPCD 2507WPath Correction Drill 3.15mm L130mm GPCD 3213Path Correction Drill 3.15mm L130mm Wide Sleeve GPCD 3213WPath Correction Drill 3.15mm L70mm GPCD 3207Path Correction Drill 3.15mm L70mm Wide Sleeve GPCD 3207WPreXolid Compact Surgical Kit CSKPreXolid Digital Analog 4.10mm L100mm, DAMPreXolid Digital Analog 4.60mm L8.50mm, DARPreXolid Digital Guide Kit DGKPreXolid Expansion Kit EPKPreXolid Impression Post Pick-up 4.80mm L100mm, MIP 48SPreXolid Impression Post Pick-up 4.80mm L100mm, MIP 48SNPreXolid Impression Post Pick-up 4.80mm L150mm, MIP 48LPreXolid Impression Post Pick-up 4.80mm L150mm, MIP 48LNPreXolid Impression Post Pick-up 40mm L150mm, MIP 40LPreXolid Impression Post Pick-up 40mm L150mm, MIP 40LNPreXolid Impression Post Pick-up 5.50mm L100mm, MIP 55SPreXolid Impression Post Pick-up 5.50mm L100mm, MIP 55SNPreXolid Impression Post Pick-up 5.50mm L150mm, MIP 55LPreXolid Impression Post Pick-up 5.50mm L150mm, MIP 55LNPreXolid Impression Post Pick-up Mini 4.50mm L110mm, IPM 45SPreXolid Impression Post Pick-up Mini 4.50mm L150mm, IPM 45LPreXolid Impression Post Pick-up Mini 40mm L110mm, IPM 40SPreXolid Impression Post Pick-up Mini 40mm L150mm, IPM 40LPreXolid Impression Post Pick-up Regular 4.50mm L110mm, IPR 45SPreXolid Impression Post Pick-up Regular 4.50mm L150mm, IPR 45LPreXolid Impression Post Pick-up Regular 40mm L110mm, IPR 40SPreXolid Impression Post Pick-up Regular 40mm L150mm, IPR 40LPreXolid Impression Post Pick-up Regular 50mm L110mm, IPR 50SPreXolid Impression Post Pick-up Regular 50mm L150mm, IPR 50LPreXolid Impression Post Transfer 4.80mm L80mm, MIT 48PreXolid Impression Post Transfer 5.50mm L80mm, MIT 55PreXolid Impression Post Transfer Mini 4.50mm L110mm, ITM 45SPreXolid Impression Post Transfer Mini 4.50mm L140mm, ITM 45LPreXolid Impression Post Transfer Mini 40mm L110mm, ITM 40SPreXolid Impression Post Transfer Mini 40mm L140mm, ITM 40LPreXolid Impression Post Transfer Regular 4.50mm L110mm, ITR 45SPreXolid Impression Post Transfer Regular 4.50mm L140mm, ITR 45LPreXolid Impression Post Transfer Regular 40mm L110mm, ITR 40SPreXolid Impression Post Transfer Regular 40mm L140mm, ITR 40LPreXolid Impression Post Transfer Regular 50mm L110mm, ITR 50SPreXolid Impression Post Transfer Regular 50mm L140mm, ITR 50LPreXolid Lab Analog 3.20mm L90mm, LAM 32PreXolid Lab Analog 3.75mm L90mm, LAM 37PreXolid Lab Analog 4.25mm L90mm, LAR 42PreXolid Lab Analog 4.60mm L120mm, LAD 46PreXolid Multi Healing Cap MHCPreXolid Multi Prosthetic Screw MPSPreXolid Multi-Unit Analog 4.80mm L120mm, MUA 48PreXolid Multi-Unit Analog 5.50mm L120mm, MUA 55PreXolid Multi-Unit Ti-Base 40mm MTA 0405PreXolid Multi-Unit Ti-Base 40mm MTA 0410	2025

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Eclectic Co., Ltd. as the applicant.

Decided	510(k)	Device	Device type
18 Oct 2024	K240725	PreXolid CAD/CAM abutments	NHA Endosseous Dental Implant Abutment

Also lists devices cleared under other names

Eclectic Co., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Hoowon Edi Co., Ltd. (1).

Decided	510(k)	Device	Applicant	Device type
24 May 2024	K231426	8plant Implant System	Hoowon Edi Co., Ltd.	DZE Root-Form Endosseous Implant

Registered establishments

Establishment	Location	What it does
ECLECTIC INC.FDA reg. 3029820793	Hwaseong-si Gyeonggi, South Korea	Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10091703). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.