The following data is part of a premarket notification filed by Ronvig A/s with the FDA for Dento-prep Particle Microblaster.
| Device ID | K010816 |
| 510k Number | K010816 |
| Device Name: | DENTO-PREP PARTICLE MICROBLASTER |
| Classification | Airbrush |
| Applicant | RONVIG A/S GL VEJLEVELJ 57-59 Dk-8721 Daugaard, DK Dk-8721 |
| Contact | Annette Ravn Nielsen |
| Correspondent | Annette Ravn Nielsen RONVIG A/S GL VEJLEVELJ 57-59 Dk-8721 Daugaard, DK Dk-8721 |
| Product Code | KOJ |
| CFR Regulation Number | 872.6080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-19 |
| Decision Date | 2001-05-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05713513000164 | K010816 | 000 |