The following data is part of a premarket notification filed by Takara Belmont Usa, Inc. with the FDA for Belmont Quolis 5000 Series Dental Unit.
| Device ID | K072273 |
| 510k Number | K072273 |
| Device Name: | BELMONT QUOLIS 5000 SERIES DENTAL UNIT |
| Classification | Unit, Operative Dental, Accessories |
| Applicant | TAKARA BELMONT USA, INC. 1129 BLOOMFIELD AVENUE West Caldwell, NJ 07006 |
| Contact | Robert Schiff |
| Correspondent | Robert Schiff TAKARA BELMONT USA, INC. 1129 BLOOMFIELD AVENUE West Caldwell, NJ 07006 |
| Product Code | NRD |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-15 |
| Decision Date | 2007-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04952195344505 | K072273 | 000 |
| 04952195089406 | K072273 | 000 |
| 04952195344598 | K072273 | 000 |
| 04952195089413 | K072273 | 000 |