Manufacturer registered with FDA
Kaiser Precision Co.
Hwaseong, South Korea. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 46
- 510(k) clearances
- 0as applicant
- Markets registered in
- 621 registrations outside the US
- Establishments
- 1South Korea
Registered in 6 markets
Where regulators' registries name Kaiser Precision Co. 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 | Kaiser Precision Co. | 2 device types | — | Below |
| Australia | TGA | Manufacturer | Kaiser Precision Co | 12 | 2022–2022 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | KAISERPRECISION CO. | 5 | 2016–2021 | Pure Global AI |
| Israel | AMAR | Manufacturer | Kaiserprecision CoKaiserprecision Co. | 2 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | KAISER PRECISION CO. | 1 | 2015–2015 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | KAISERPRECISION CO. | 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 Kaiser Precision Co. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Drill ExtensionLifting DrillLindemann DrillPoint DrillRound BurSINUS CRESTAL DRILL (SCDRILL24, SCDRILL28, SCDRILL32, SCDRILL36, SCDRILL44)SINUS CRESTAL INITIAL DRILL (SCINTDRILL)SINUS DRILL (SSC 25, SSC 30, SSC 33, SSC 42, SSC 45)SINUS LATERAL DRILL (SLDR2065, SLDR2075, SLDR2085, SLDR3565, SLDR3575, SLDR3585)SINUS LATERAL NUMBER 6 BUR (SLBUR6) 9 moreStep DrillStraight DrillTorque RatchetTorque WrenchTrephine DrillZirconia Crestal DrillZIrconia Dome DrillZirconia Drill (ZID)Zirconia Round Bur | 2013 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Dr.Eagles Sinus CASE (ESKCASE)Dr.Eagles Sinus Kit (ESKC)IMPLANT REMOVAL KIT (IRKIT)IMPLANT REMOVAL KIT CASE (IRCASE)IMPLANT REMOVAL RATCHET WRENCH (IRRW)IMPLANT REMOVAL SCREW REPLACEMENT (IRSR14, IRSR16, IRSR18, IRSR172, IRSR20, IRSR25)IMPLANT REMOVER (IR315, IR415, IR515, IR615, IR320, IR420, IR520, IR620)SCREW DRIVER (SD7, SD12, SD17)SINUS COMBO KIT (SCOMKIT)SINUS CRESTAL APPROACH KIT VERSION 2 (SCAKITV2) 17 moreSINUS CRESTAL BONE CONDENSER (SCBONECNDSR)SINUS CRESTAL BONE SYRINGE (SCBONESYR)SINUS CRESTAL DEPTH GAUGE (SCDPTHGAUGE)SINUS CRESTAL INSERTER (SCINSERTER)SINUS CRESTAL KIT CASE (SCACASE)SINUS CRESTAL SPREADER (SCSPRDR27, SCSPRDR31, SCSPRDR39)SINUS CRESTAL STOPPER (SCSTOPPER02, SCSTOPPER03, SCSTOPPER04, SCSTOPPER05, SCSTOPPER06)SINUS CRESTAL STOPPER (SCSTOPPER07, SCSTOPPER08, SCSTOPPER09, SCSTOPPER10, SCSTOPPER11)SINUS CRESTAL STOPPER HOLDERS (SCSTPRHLDR)SINUS DEPTH GAGE (SDG)SINUS LATERAL APPROACH KIT VERSION 3 (SLAKITV3)SINUS LATERAL ELEVATOR (SLELV1, SLELV2, SLELV3)SINUS LATERAL KIT CASE (SLACASE)SINUS STOPPER (SDS 040, SDS 050, SDS 060, SDS 070, SDS 080, SDS 090, SDS 100)SINUS STOPPER HOLDER (SDSP)Zirconia Bone CollectorZirconia Bone Expander | 2015 |
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 |
|---|---|---|
| KAISER PRECISION CO.FDA reg. 3010654657 | Hwaseong Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10045809). 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.