The following data is part of a premarket notification filed by Health Technology Of America, Inc. with the FDA for T.r.s.: Tooth Replacement System.
| Device ID | K891119 |
| 510k Number | K891119 |
| Device Name: | T.R.S.: TOOTH REPLACEMENT SYSTEM |
| Classification | Attachment, Precision, All |
| Applicant | HEALTH TECHNOLOGY OF AMERICA, INC. 301 WEST 53RD ST. APARTMENT 21K New York, NY 10019 |
| Contact | Howard Marshall |
| Correspondent | Howard Marshall HEALTH TECHNOLOGY OF AMERICA, INC. 301 WEST 53RD ST. APARTMENT 21K New York, NY 10019 |
| Product Code | EGG |
| CFR Regulation Number | 872.3165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-02 |
| Decision Date | 1989-04-17 |