The following data is part of a premarket notification filed by Datum Dental Ltd. with the FDA for Ossix Volumax.
| Device ID | K153549 |
| 510k Number | K153549 |
| Device Name: | OSSIX VOLUMAX |
| Classification | Barrier, Animal Source, Intraoral |
| Applicant | Datum Dental Ltd. 1 Bat Sheva St., PO Box 6170 Lod, IL 7116003 |
| Contact | Arie Goldlust |
| Correspondent | Janice M. Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103 |
| Product Code | NPL |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-11 |
| Decision Date | 2016-08-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290015477147 | K153549 | 000 |
| 07290015477130 | K153549 | 000 |
| 07290015477123 | K153549 | 000 |
| 07290015477116 | K153549 | 000 |