The following data is part of a premarket notification filed by Scheu-dental with the FDA for De-bond 200.
| Device ID | K883418 |
| 510k Number | K883418 |
| Device Name: | DE-BOND 200 |
| Classification | File, Pulp Canal, Endodontic |
| Applicant | SCHEU-DENTAL ONE FARRAGUT SQUARE SOUTH, NW Washington, DC 20006 |
| Contact | Lothar Griessbach |
| Correspondent | Lothar Griessbach SCHEU-DENTAL ONE FARRAGUT SQUARE SOUTH, NW Washington, DC 20006 |
| Product Code | EKS |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-15 |
| Decision Date | 1989-10-24 |