510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K954662Substantially Equivalent

Thermalastic/tripolyvinalene

Tak Systems, Wareham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954662 is the FDA 510(k) clearance record for THERMALASTIC/TRIPOLYVINALENE, a class II device, cleared for Tak Systems on under FDA product code ELW (Material, Impression). FDA records list one 510(k) clearance for Tak Systems. As of , FDA records show no recalls naming K954662.

Clearance record

Decision date
Received
(36 days to decision)
Product code
ELW Material, Impression
Regulation
21 CFR 872.3660
Device class
Class II
Review panel
Dental
Applicant
Tak Systems 14 Kendrick Rd., Wareham MA
510(k) summary
Summary
Third party review
No

Clearances, product code ELW

Trailing 12 months
3 clearances under product code ELW in the twelve months to October 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code ELW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20262
October 20260