The following data is part of a premarket notification filed by Biotech Medical Instruments Corp. with the FDA for Various Dental Implants.
| Device ID | K982111 |
| 510k Number | K982111 |
| Device Name: | VARIOUS DENTAL IMPLANTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BIOTECH MEDICAL INSTRUMENTS CORP. 832 MARSEILLES-GALION RD. W. Marion, OH 43302 |
| Contact | William Simmons |
| Correspondent | William Simmons BIOTECH MEDICAL INSTRUMENTS CORP. 832 MARSEILLES-GALION RD. W. Marion, OH 43302 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-16 |
| Decision Date | 1998-09-15 |