510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K980616Substantially Equivalent

Permafix Chairside Soft Denture Relining (7010) (7011-13) (7014-15)

Kohler Medizintechnik GmbH & Co. KG, Neuhausen, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980616 is the FDA 510(k) clearance record for PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15), a class II device, cleared for Kohler Medizintechnik GmbH & Co. KG on under FDA product code EBI (Resin, Denture, Relining, Repairing, Rebasing). FDA records list one 510(k) clearance for Kohler Medizintechnik GmbH & Co. KG. As of , FDA records show no recalls naming K980616.

Clearance record

Decision date
Received
(71 days to decision)
Product code
EBI Resin, Denture, Relining, Repairing, Rebasing
Regulation
21 CFR 872.3760
Device class
Class II
Review panel
Dental
Applicant
Kohler Medizintechnik GmbH & Co. KG Danningen 9, Neuhausen, DE
510(k) summary
Statement
Third party review
No

Clearances, product code EBI

Trailing 12 months
10 clearances under product code EBI in the twelve months to October 2026, November 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EBI, trailing twelve months
MonthClearances
November 20253
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20263
August 20262
September 20260
October 20260