510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061264Substantially Equivalent

Tempfx Esthetic Provisional System

Dentsply International, Inc., York PA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061264 is the FDA 510(k) clearance record for TEMPFX ESTHETIC PROVISIONAL SYSTEM, a class II device, cleared for Dentsply International, Inc. on under FDA product code EBG (Crown And Bridge, Temporary, Resin). FDA records list 59 510(k) clearances for Dentsply International, Inc., from to . As of , FDA records show no recalls naming K061264.

Clearance record

Decision date
Received
(18 days to decision)
Product code
EBG Crown And Bridge, Temporary, Resin
Regulation
21 CFR 872.3770
Device class
Class II
Review panel
Dental
Applicant
Dentsply International, Inc. 221 W. Philadelphia St., SE 60, York PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EBG

Trailing 12 months
2 clearances under product code EBG in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EBG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260