The following data is part of a premarket notification filed by Mesynthes Ltd with the FDA for Endoform Dental Template.
| Device ID | K101546 |
| 510k Number | K101546 |
| Device Name: | ENDOFORM DENTAL TEMPLATE |
| Classification | Dressing, Wound, Collagen |
| Applicant | MESYNTHES LTD 49 PLAIN STREET North Attleboro, MA 02760 -2237 |
| Contact | Mary Mcnamara |
| Correspondent | Mary Mcnamara MESYNTHES LTD 49 PLAIN STREET North Attleboro, MA 02760 -2237 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-03 |
| Decision Date | 2010-06-23 |
| Summary: | summary |