510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K071632Substantially Equivalent

Perfect Tissue Contouring System II

Coltene /Whaledent AG, Cuyahoga Falls OH / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071632 is the FDA 510(k) clearance record for PERFECT TISSUE CONTOURING SYSTEM II, a class II device, cleared for Coltene/Whaledent, Inc. on under FDA product code EKZ (Unit, Electrosurgical, And Accessories, Dental). FDA records list 39 510(k) clearances for Coltene/Whaledent, Inc., from to . As of , FDA records show no recalls naming K071632.

Clearance record

Decision date
Received
(126 days to decision)
Product code
EKZ Unit, Electrosurgical, And Accessories, Dental
Regulation
21 CFR 872.4920
Device class
Class II
Review panel
Dental
Applicant
Coltene/Whaledent, Inc. 235 Ascot Pkwy., Cuyahoga Falls OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EKZ

Trailing 12 months

FDA records hold no clearances under product code EKZ in the trailing twelve months.

FDA records show no clearances under product code EKZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EKZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260