510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K897134Substantially Equivalent

Cmw Cement Pressurisation System

Dentsply Intl., York PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K897134 is the FDA 510(k) clearance record for CMW CEMENT PRESSURISATION SYSTEM, a class I device, cleared for Dentsply Intl. on under FDA product code KIH (Dispenser, Cement). FDA records list 291 510(k) clearances for Dentsply Intl., from to . As of , FDA records show no recalls naming K897134.

Clearance record

Decision date
Received
(65 days to decision)
Product code
KIH Dispenser, Cement
Regulation
21 CFR 888.4200
Device class
Class I
Review panel
Orthopedic
Applicant
Dentsply Intl. 570 W. College Ave., York PA
Third party review
No

Clearances, product code KIH

Trailing 12 months

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

FDA records show no clearances under product code KIH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KIH, 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