Manufacturer registered with FDA
Zirc Dental Products Inc
Buffalo, MN, United States. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 24
- 510(k) clearances
- 0as applicant
- Markets registered in
- 7321 registrations outside the US
- Establishments
- 1United States
Registered in 7 markets
Where regulators' registries name Zirc Dental Products 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 | Zirc Dental Products Inc | 7 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Zirc Dental Products Inc. | 305 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Zirc Dental Products, Inc.ZIRC DENTAL PRODUCTS, INC · ZIRC DENTAL PRODUCTS, INC. | 8 | 2017–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | Zirc Dental Products, Inc.ZIRC DENTAL PRODUCTS Inc. | 3 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Zirc Dental Products Inc | 2 | 2023–2023 | Pure Global AI |
| South Korea | MFDS | Manufacturer | ZIRC DENTAL PRODUCTS, INC. | 2 | 2019–2019 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | ZIRC DENTAL PRODUCTS, INC. | 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 Zirc Dental Products 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 |
|---|---|---|---|---|
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | Mr. Thirsty One-Step, Mr. Thirsty One-Step Comfort KitPink PetalSE Cushions, Lingua-Fix, Saliva Ejector, Saliva Ejector Valve, Saliva Ejector Tip | 1999 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Cement SpatulaDerlin SpatulaMighty Mixer BowlMighty Mixer SpatulaMixing SticksMixing Wells | 1999 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Crystal HD® Resin Mouth Mirror Screw-On Head Cone SocketCrystal HD® Resin Mouth Mirror Screw-On Head Cone Socket Double-SidedCrystal HD® Resin Mouth Mirror Screw-On Head Simple StemCrystal HD® Resin Mouth Mirror Soft Grip Double-SidedCrystal HD® Soft Grip Resin Mouth MirrorCrystal HD® Stainless Steel Mouth Mirror Screw-On HeadsCrystal HD® Thin Grip Resin Mouth MirrorMirror Magic Anti-Fog System | 1992 |
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | Water Wise Starter Kit, Water Wise Replacement Bottle | 2025 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | Airway ArmorLatex-Free Insti-Dam Relaxed Fit, Latex-Free Insti-Dam | 2000 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Ergo Grip Cone Socket Mirror HandleErgo Grip Simple Stem Mirror HandleSoft Grip Cone Socket Mirror Handle | 2006 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Maker | Matrix Dispenser | 2025 |
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 |
|---|---|---|
| ZIRC DENTAL PRODUCTS, INC.FDA reg. 2126387 | BUFFALO, MN, United States | Complaint file establishment, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2126387). 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.