The following data is part of a premarket notification filed by Amc General, Inc. with the FDA for Race Endodontic File.
| Device ID | K002709 |
| 510k Number | K002709 |
| Device Name: | RACE ENDODONTIC FILE |
| Classification | Handpiece, Belt And/or Gear Driven, Dental |
| Applicant | AMC GENERAL, INC. 800 KING GEORGE BLVD. Savannah, GA 31419 |
| Contact | Ray T Burke |
| Correspondent | Ray T Burke AMC GENERAL, INC. 800 KING GEORGE BLVD. Savannah, GA 31419 |
| Product Code | EFA |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-30 |
| Decision Date | 2000-11-17 |