The following data is part of a premarket notification filed by Healthline Implants, Inc. with the FDA for Various Dental Implants With Various Abutments.
| Device ID | K981954 |
| 510k Number | K981954 |
| Device Name: | VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS |
| Classification | Blade-form Endosseous Dental Implant |
| Applicant | HEALTHLINE IMPLANTS, INC. 832 MARSEILLES-GALION RD W Marion, OH |
| Contact | William Simmons |
| Correspondent | William Simmons HEALTHLINE IMPLANTS, INC. 832 MARSEILLES-GALION RD W Marion, OH |
| Product Code | NRQ |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-04 |
| Decision Date | 1999-01-25 |