The following data is part of a premarket notification filed by Kohler Medizintechnik Gmbh & Co. Kg with the FDA for Permafix Chairside Soft Denture Relining (7010) (7011-13) (7014-15).
| Device ID | K980616 |
| 510k Number | K980616 |
| Device Name: | PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15) |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | KOHLER MEDIZINTECHNIK GMBH & CO. KG DANNINGEN 9 Neuhausen, DE D-78579 |
| Contact | Dagmar S Maser |
| Correspondent | Dagmar S Maser KOHLER MEDIZINTECHNIK GMBH & CO. KG DANNINGEN 9 Neuhausen, DE D-78579 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-18 |
| Decision Date | 1998-04-30 |