The following data is part of a premarket notification filed by Takara Belmont Corporation with the FDA for Evogue Dental Unit.
| Device ID | K152100 |
| 510k Number | K152100 |
| Device Name: | Evogue Dental Unit |
| Classification | Unit, Operative Dental |
| Applicant | TAKARA BELMONT CORPORATION 1-1-2 CHOME, HIGASHI-SHINSAIBASHI, CHUO-KU Osaka, JP 542-0083 |
| Contact | Toshinori Kiyomatsu |
| Correspondent | Robert Schiff Schiff & Company, Inc. 1120 Bloomfield Ave West Caldwell, NJ 07006 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-28 |
| Decision Date | 2016-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04952195257690 | K152100 | 000 |
| 04952195414574 | K152100 | 000 |
| 04952195254798 | K152100 | 000 |
| 04952195254835 | K152100 | 000 |
| 04952195254842 | K152100 | 000 |
| 04952195257683 | K152100 | 000 |
| 04952195257706 | K152100 | 000 |
| 04952195257713 | K152100 | 000 |
| 04952195257720 | K152100 | 000 |
| 04952195257737 | K152100 | 000 |
| 04952195264223 | K152100 | 000 |
| 04952195264230 | K152100 | 000 |
| 04952195264315 | K152100 | 000 |
| 04952195288052 | K152100 | 000 |
| 04952195288069 | K152100 | 000 |
| 04952195288076 | K152100 | 000 |
| 04952195257577 | K152100 | 000 |
| 04952195408504 | K152100 | 000 |