The following data is part of a premarket notification filed by Danville Materials, Inc. with the FDA for Turbo Temp 3.
| Device ID | K102753 |
| 510k Number | K102753 |
| Device Name: | TURBO TEMP 3 |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | DANVILLE MATERIALS, INC. 3420 FOSTORIA WAY, SUITE A-200 San Ramon, CA 94583 |
| Contact | Lindsay Tilton |
| Correspondent | Lindsay Tilton DANVILLE MATERIALS, INC. 3420 FOSTORIA WAY, SUITE A-200 San Ramon, CA 94583 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-23 |
| Decision Date | 2011-02-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817169020165 | K102753 | 000 |
| 00854212006639 | K102753 | 000 |
| 00854212006622 | K102753 | 000 |
| 00854212006615 | K102753 | 000 |
| 20843471128583 | K102753 | 000 |
| 10843471128265 | K102753 | 000 |
| 10843471128210 | K102753 | 000 |
| 20843471128200 | K102753 | 000 |
| 20843471128194 | K102753 | 000 |
| 00854212006646 | K102753 | 000 |
| 00854212006653 | K102753 | 000 |
| 00817169020158 | K102753 | 000 |
| 00817169020141 | K102753 | 000 |
| 00816577020118 | K102753 | 000 |
| 00816577020101 | K102753 | 000 |
| 00816577020095 | K102753 | 000 |
| 00816577020088 | K102753 | 000 |
| 00816577020071 | K102753 | 000 |
| 00854212006660 | K102753 | 000 |
| 20843471128170 | K102753 | 000 |