Manufacturer registered with FDA
Unique Instruments Inc.
Bridgeport, MI, United States. Lists 11 dental device types with FDA across 1 registered establishment.
- Device types listed
- 11
- Brands and models
- 45
- 510(k) clearances
- 0as applicant
- Markets registered in
- 33 registrations outside the US
- Establishments
- 1United States
Registered in 3 markets
Where regulators' registries name Unique Instruments Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Unique Instruments Inc. | 11 device types | — | Below |
| Taiwan | TFDA | Manufacturer | Unique Instruments Inc. | 2 | 2025–2025 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | ORCHID UNIQUE | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Unique Instruments Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | ACE Mini Bone Plate SystemRESORBABLE FIXATION SYSTEMSYNTHES CRANIOFACIAL PLATES | 2012 |
| Manual Wire Driver and Bone DrillDZJ · Class 2 | Surgical drills & motors | Maker | cross cut fissure burDENTAL BONE CUTTING INSTRUMENTS | 2013 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Genesis Implant SystemTAPERED DRILL FOR ? 9 MAX | 2012 |
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Maker | DRILL, W/STOP J-NOTCH, 2 FL, 1.7MM 310M403DRILL, W/STOP J-NOTCH, 2 FL, 1.7MM 310M406DRILL, W/STOP J-NOTCH, 2FL, 1.7MM 310M404DRILL, W/STOP J-NOTCH, 2FL, 1.7MM 310M405DRILL, W/STOP J-NOTCH, 2FL, 1.7MM 310M407DRILL, W/STOP J-NOTCH, 2FL, 1.7MM 310M408DRL, Q.C., 2-FL, 1.7 MMDRL, TIN, QC, 2 FL, 2.5MMDRL, UNIV-HALL, 2-FL, 1.5MMSD03.503.410-US JABIL 18 moreSD03.503.414-US JABILSD03.503.416-US JABILSD03.503.418-US JABILSD03.503.420-US JABILSD03.503.422-US JABILSD03.503.476-US JABILSD03.503.704-US JABILSD03.503.706-US JABILSD03.503.708-US JABILSD03.503.710-US JABILSD03.503.712-US JABILSD03.503.714-US JABILSD03.503.716-US JABILSD03.503.718-US JABILSD03.503.720-US JABILSD03.503.722-US JABILSD03.511.342-US JABILSynthes Electric Pen Drive System | 2016 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | RAPIDSORB PLUS SCREW SYSTEM | 2017 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | MICDRILL LONG ATTAC IRR. CLIP 5100-015-0271MICRODRILL ATTACH. IRR. CLIP 5100-015-251TPS MICRO OSC SAW IRR. CLIP 5100-031-500 | 2020 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | dental bur | 2012 |
| Surgical Osteotome ChiselEMM · Class 1 | Dental hand instruments | Maker | osteotome | 2012 |
| Implant Temporomandibular JointLZD · Class 3 | — | Maker | Diamond Bur | 2013 |
| External Mandibular Fixator and/or DistractorMQN · Class 2 | Maxillofacial plates & screws | Maker | Synthes External Midface Distractor | 2017 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | dental drillDRL, CONTRA, 3-FL, 4.4MM X --MM | 2012 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ORCHID UNIQUEFDA reg. 1828288 | Bridgeport, MI, United States | Contract manufacturer |
Other names on FDA records
Orchid Unique
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10042005). 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.