Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Buffalo Dental Mfg. Co., Inc. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
94 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K955573 | OPTIBLAST INTRAORAL SANDBLASTER | Buffalo Dental Mfg. Co., Inc. | 1996-05-03 | 148 | 0 |
| K945220 | AMALGAM CARRIER | Buffalo Dental Mfg. Co., Inc. | 1995-01-11 | 77 | 0 |
| K941954 | NON-FOGGING DENTAL MIRROR | Buffalo Dental Mfg. Co., Inc. | 1994-07-08 | 77 | 0 |
| K841491 | CONVENTIONAL PLASTIC DENTAL TRAYS | Buffalo Dental Mfg. Co., Inc. | 1984-07-13 | 94 | 0 |
| K841323 | FUZZY TRAY | Buffalo Dental Mfg. Co., Inc. | 1984-06-27 | 86 | 0 |
| K841490 | POLYSULFIDE CUSTOM TRAY MATERIAL | Buffalo Dental Mfg. Co., Inc. | 1984-06-27 | 78 | 0 |
| K820489 | ULTRAFINE TRAY ADHESIVE | Buffalo Dental Mfg. Co., Inc. | 1982-03-19 | 24 | 0 |
| K820216 | ULTRA-WET | Buffalo Dental Mfg. Co., Inc. | 1982-02-24 | 29 | 0 |
| K802990 | ALGINATE/SILICONE CROWN & BRIDGE MATER | Buffalo Dental Mfg. Co., Inc. | 1981-02-02 | 70 | 0 |
| K802882 | HYDROCOLLOID COMPATIBLE CREAM ALGINATE | Buffalo Dental Mfg. Co., Inc. | 1981-01-28 | 72 | 0 |
| K802662 | POLYCARBONATE TEMPORARY CEMENT | Buffalo Dental Mfg. Co., Inc. | 1980-12-16 | 49 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda