The following data is part of a premarket notification filed by Thermoelastic Technologies, Inc. with the FDA for Bitem Angel Reline Kit, Bitem Laboratory Kit, Models 120110, 120060.
| Device ID | K012882 |
| 510k Number | K012882 |
| Device Name: | BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060 |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | THERMOELASTIC TECHNOLOGIES, INC. 962 ALLEGRO LN. Apollo Beach, FL 33572 |
| Contact | Art Ward |
| Correspondent | Art Ward THERMOELASTIC TECHNOLOGIES, INC. 962 ALLEGRO LN. Apollo Beach, FL 33572 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-28 |
| Decision Date | 2001-11-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H66810140391 | K012882 | 000 |
| H66810140181 | K012882 | 000 |
| H66810140171 | K012882 | 000 |
| H66810140161 | K012882 | 000 |
| H66810140151 | K012882 | 000 |
| H66810140141 | K012882 | 000 |
| H66810140131 | K012882 | 000 |
| H66810140121 | K012882 | 000 |
| H66810140111 | K012882 | 000 |
| H66810140101 | K012882 | 000 |
| H66810140191 | K012882 | 000 |
| H66810140201 | K012882 | 000 |
| H66810140341 | K012882 | 000 |
| H66810140331 | K012882 | 000 |
| H66810140321 | K012882 | 000 |
| H66810140311 | K012882 | 000 |
| H66810140251 | K012882 | 000 |
| H66810140241 | K012882 | 000 |
| H66810140231 | K012882 | 000 |
| H66810140221 | K012882 | 000 |
| H66810140211 | K012882 | 000 |
| H66810140261 | K012882 | 000 |