The following data is part of a premarket notification filed by Sci-pharm, Inc. with the FDA for Micro Join, Crown & Bridge Adhesive.
| Device ID | K823935 |
| 510k Number | K823935 |
| Device Name: | MICRO JOIN, CROWN & BRIDGE ADHESIVE |
| Classification | Cement, Dental |
| Applicant | SCI-PHARM, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-29 |
| Decision Date | 1983-02-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D801SP52055B1 | K823935 | 000 |
| D801SP50251 | K823935 | 000 |
| D801SP50251B1 | K823935 | 000 |
| D801SP50251N1 | K823935 | 000 |
| D801SP50252B1 | K823935 | 000 |
| D801SP50252N1 | K823935 | 000 |
| D801SP502532B1 | K823935 | 000 |
| D801SP50253B1 | K823935 | 000 |
| D801SP50253N1 | K823935 | 000 |
| D801SP50254B1 | K823935 | 000 |
| D801SP50254N1 | K823935 | 000 |
| D801SP50255B1 | K823935 | 000 |
| D801SP50255N1 | K823935 | 000 |
| D801SP50256N1 | K823935 | 000 |
| D801SP50261 | K823935 | 000 |
| D801SFRCB1 | K823935 | 000 |