Submission Details
| 510(k) Number | K780743 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 13, 1978 |
| Decision Date | May 12, 1978 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
Cleared
Traditional
K780743 - CLAMP FORCEPS
(FDA 510(k) Clearance)
May 1978
Decision
29d
Days
Class 1
Risk
K780743 is an FDA 510(k) clearance for the CLAMP FORCEPS. This device is classified as a Forceps, Rubber Dam Clamp (Class I — General Controls, product code EJG).
Submitted by Hygienic Dental Mfg., Co., The (Mchenry, US). The FDA issued a Cleared decision on May 12, 1978, 29 days after receiving the submission on April 13, 1978.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6300.
Device Classification
| Product Code | EJG — Forceps, Rubber Dam Clamp |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.6300 |