The following data is part of a premarket notification filed by B & H Technical Services Ltd. with the FDA for Acetal Dental/preformed Clasp.
| Device ID | K954971 |
| 510k Number | K954971 |
| Device Name: | ACETAL DENTAL/PREFORMED CLASP |
| Classification | Clasp, Preformed |
| Applicant | B & H TECHNICAL SERVICES LTD. 2020 124TH AVE., N.E. SUITE C-106 Bellevue, WA 98005 |
| Contact | Raymond Chinea |
| Correspondent | Raymond Chinea B & H TECHNICAL SERVICES LTD. 2020 124TH AVE., N.E. SUITE C-106 Bellevue, WA 98005 |
| Product Code | EHP |
| CFR Regulation Number | 872.3285 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-27 |
| Decision Date | 1995-12-11 |