The following data is part of a premarket notification filed by Southern Dental Industries, Inc. with the FDA for Alloybond.
| Device ID | K981383 |
| 510k Number | K981383 |
| Device Name: | ALLOYBOND |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | SOUTHERN DENTAL INDUSTRIES, INC. 246 FIRST ST., SUITE 204 San Francisco, CA 94105 |
| Contact | Samantha J Cheetham |
| Correspondent | Samantha J Cheetham SOUTHERN DENTAL INDUSTRIES, INC. 246 FIRST ST., SUITE 204 San Francisco, CA 94105 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-16 |
| Decision Date | 1998-06-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| DO3655440121 | K981383 | 000 |
| DO3655440111 | K981383 | 000 |
| DO3655440101 | K981383 | 000 |
| DO3655440011 | K981383 | 000 |