510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K864720Substantially Equivalent

Light-Cured Periodontal Dressing

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

K864720 is the FDA 510(k) clearance record for LIGHT-CURED PERIODONTAL DRESSING, a class II device, cleared for Dentsply Intl. on under FDA product code EMA (Cement, Dental). FDA records list 291 510(k) clearances for Dentsply Intl., from to . As of , FDA records show no recalls naming K864720.

Clearance record

Decision date
Received
(125 days to decision)
Product code
EMA Cement, Dental
Regulation
21 CFR 872.3275
Device class
Class II
Review panel
Dental
Applicant
Dentsply Intl. 570 W. College Ave., York PA
Third party review
No

Clearances, product code EMA

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