The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Remin Pro.
| Device ID | K101104 |
| 510k Number | K101104 |
| Device Name: | REMIN PRO |
| Classification | Agent, Polishing, Abrasive, Oral Cavity |
| Applicant | VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Contact | M. Th Plaumann |
| Correspondent | M. Th Plaumann VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Product Code | EJR |
| CFR Regulation Number | 872.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-20 |
| Decision Date | 2010-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22120091 | K101104 | 000 |
| E22120071 | K101104 | 000 |
| E22120061 | K101104 | 000 |
| E22120051 | K101104 | 000 |
| E22120041 | K101104 | 000 |
| E22120031 | K101104 | 000 |