The following data is part of a premarket notification filed by Southern Dental Industries, Inc. with the FDA for Sdi Composties.
| Device ID | K941899 |
| 510k Number | K941899 |
| Device Name: | SDI COMPOSTIES |
| Classification | Material, Tooth Shade, Resin |
| Applicant | SOUTHERN DENTAL INDUSTRIES, INC. 7020 KOLL CENTER PKWY. SUITE 140 Pleasanton, CA 94566 |
| Contact | Judy Hagenbaugh |
| Correspondent | Judy Hagenbaugh SOUTHERN DENTAL INDUSTRIES, INC. 7020 KOLL CENTER PKWY. SUITE 140 Pleasanton, CA 94566 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-19 |
| Decision Date | 1994-07-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| DO3670000051 | K941899 | 000 |
| DO3670114161 | K941899 | 000 |
| DO3670122231 | K941899 | 000 |
| DO3670122241 | K941899 | 000 |
| DO3670123241 | K941899 | 000 |
| DO3670124251 | K941899 | 000 |
| DO3670124261 | K941899 | 000 |
| DO3670133341 | K941899 | 000 |
| DO3670133351 | K941899 | 000 |
| DO3670141421 | K941899 | 000 |
| DO3670151511 | K941899 | 000 |
| DO3670114151 | K941899 | 000 |
| DO3670113151 | K941899 | 000 |
| DO3670113141 | K941899 | 000 |
| DO3670101021 | K941899 | 000 |
| DO3670102031 | K941899 | 000 |
| DO3670102041 | K941899 | 000 |
| DO3670103041 | K941899 | 000 |
| DO3670103051 | K941899 | 000 |
| DO3670104051 | K941899 | 000 |
| DO3670104061 | K941899 | 000 |
| DO3670105061 | K941899 | 000 |
| DO3670111121 | K941899 | 000 |
| DO3670112111 | K941899 | 000 |
| DO3670300011 | K941899 | 000 |
| DO3674500011 | K941899 | 000 |
| DO3674500151 | K941899 | 000 |
| DO3674500171 | K941899 | 000 |
| DO3674500201 | K941899 | 000 |
| DO3674541511 | K941899 | 000 |
| DO3679000001 | K941899 | 000 |
| DO3681000391 | K941899 | 000 |
| DO3681000401 | K941899 | 000 |
| DO3681000451 | K941899 | 000 |
| DO3681000521 | K941899 | 000 |
| DO3681000591 | K941899 | 000 |
| DO3674500141 | K941899 | 000 |
| DO3674500131 | K941899 | 000 |
| DO3674500121 | K941899 | 000 |
| DO3674500021 | K941899 | 000 |
| DO3674500031 | K941899 | 000 |
| DO3674500041 | K941899 | 000 |
| DO3674500051 | K941899 | 000 |
| DO3674500061 | K941899 | 000 |
| DO3674500071 | K941899 | 000 |
| DO3674500081 | K941899 | 000 |
| DO3674500091 | K941899 | 000 |
| DO3674500101 | K941899 | 000 |
| DO3674500111 | K941899 | 000 |
| DO3685001011 | K941899 | 000 |