Manufacturer registered with FDA
Buffalo Dental Mfg. Co., Inc.
Syosset, NY, United States. Lists 14 dental device types with FDA across 2 registered establishments, and holds 11 510(k) clearances as applicant.
- Device types listed
- 14
- Brands and models
- 16
- 510(k) clearances
- 111980–1996
- Markets registered in
- 1United States
- Establishments
- 2United States
510(k) clearances per year, 1980–2026
Devices listed with FDA
What Buffalo Dental Mfg. Co., 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 |
|---|---|---|---|---|
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Vacuum Forming Materials, EVA, Buff-Tuff | 2006 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Abbott Robinson Porte Polishers | 2006 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | Tray and Temporary Splint | 2026 |
| Articulation Paper ForcepsEFK · Class 1 | Dental hand instruments | Lister | MILLER FORCEPS | 2006 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Lister | Buffal Dental Tweezers and Forceps | 2012 |
| Intraoral Dental WaxEGD · Class 1 | — | Lister | Buffalo Dental Wax | 2007 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Lister | ABRASIVES | 2006 |
| Dental Wax CarverEIK · Class 1 | Dental hand instruments | Lister | DENTAL WAX CARVER | 2006 |
| Collar and Crown ScissorsEIR · Class 1 | Dental hand instruments | Lister | BUFFALO CROWNCOLLAR SHEARS | 2006 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | DENTAL BUR | 2006 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Maker | Buffalo Articulator | 2006 |
| Operative Amalgam CarrierEKI · Class 1 | Dental hand instruments | Maker | FEATHERWEIGHTMILLENIUM | 2006 |
| Surgical HemostatEMD · Class 1 | Dental hand instruments | Lister | HEMOSTAT | 2006 |
| Disposable Fluoride TrayKMT · Class 1 | — | Maker | Disposable Fluoride Trays, Vacuum Forming Materials | 2012 |
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 Buffalo Dental Mfg. Co., Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 3 May 1996 | K955573 | OPTIBLAST INTRAORAL SANDBLASTER | KOJ Airbrush |
| 11 Jan 1995 | K945220 | AMALGAM CARRIER | EKI Operative Amalgam Carrier |
| 8 Jul 1994 | K941954 | NON-FOGGING DENTAL MIRROR | EKJ Operative Burnisher |
| 13 Jul 1984 | K841491 | CONVENTIONAL PLASTIC DENTAL TRAYS | EHY Preformed Impression Tray |
| 27 Jun 1984 | K841490 | POLYSULFIDE CUSTOM TRAY MATERIAL | ELW Impression Material |
| 27 Jun 1984 | K841323 | FUZZY TRAY | EHY Preformed Impression Tray |
| 19 Mar 1982 | K820489 | ULTRAFINE TRAY ADHESIVE | ELW Impression Material |
| 24 Feb 1982 | K820216 | ULTRA-WET | ELW Impression Material |
| 2 Feb 1981 | K802990 | ALGINATE/SILICONE CROWN & BRIDGE MATER | ELW Impression Material |
| 28 Jan 1981 | K802882 | HYDROCOLLOID COMPATIBLE CREAM ALGINATE | ELW Impression Material |
| 16 Dec 1980 | K802662 | POLYCARBONATE TEMPORARY CEMENT | EMA Dental Cement |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Buffalo Dental Mfg Co IncFDA reg. 3007177751 | Hancock, NY, United States | Manufacturer, Repacker / relabeler |
| BUFFALO DENTAL MFG. CO., INC.FDA reg. 2411056 | SYOSSET, NY, United States | Complaint file establishment, Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2411056). 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.