Buffalo Dental Mfg. Co., Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Buffalo Dental Mfg. Co., Inc.” (first 1980, latest 1996), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 77 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ELW | Material, Impression | 5 | 5 |
| EHY | Tray, Impression, Preformed | 2 | 2 |
| EKI | Carrier, Amalgam, Operative | 1 | 1 |
| EKJ | Burnisher, Operative | 1 | 1 |
| EMA | Cement, Dental | 1 | 1 |
| KOJ | Airbrush | 1 | 1 |
Review panels
- Dental (11)
Most recent Buffalo Dental Mfg. Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955573 | OPTIBLAST INTRAORAL SANDBLASTER | KOJ | 1996-05-03 | 148 |
| K945220 | AMALGAM CARRIER | EKI | 1995-01-11 | 77 |
| K941954 | NON-FOGGING DENTAL MIRROR | EKJ | 1994-07-08 | 77 |
| K841491 | CONVENTIONAL PLASTIC DENTAL TRAYS | EHY | 1984-07-13 | 94 |
| K841490 | POLYSULFIDE CUSTOM TRAY MATERIAL | ELW | 1984-06-27 | 78 |
| K841323 | FUZZY TRAY | EHY | 1984-06-27 | 86 |
| K820489 | ULTRAFINE TRAY ADHESIVE | ELW | 1982-03-19 | 24 |
| K820216 | ULTRA-WET | ELW | 1982-02-24 | 29 |
| K802990 | ALGINATE/SILICONE CROWN & BRIDGE MATER | ELW | 1981-02-02 | 70 |
| K802882 | HYDROCOLLOID COMPATIBLE CREAM ALGINATE | ELW | 1981-01-28 | 72 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Buffalo Dental Mfg. Co., Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Buffalo Filter Co., Inc. (24 510(k)s)
- Buffalo Medical Specialties Mfg., Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Buffalo Dental Mfg. Co., Inc.?
FDA lists 11 510(k) clearances under the applicant name “Buffalo Dental Mfg. Co., Inc.” (first 1980, latest 1996), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Buffalo Dental Mfg. Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Buffalo Dental Mfg. Co., Inc. is 77 days.
Which FDA product codes appear under Buffalo Dental Mfg. Co., Inc.?
The most frequent FDA product codes under this applicant name are ELW (Material, Impression, 5); EHY (Tray, Impression, Preformed, 2); EKI (Carrier, Amalgam, Operative, 1).
Next steps
- See all 11 Buffalo Dental Mfg. Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code ELW, Buffalo Dental Mfg. Co., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.