510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062828Substantially Equivalent

Mouthguard and Aligner Materials

Dentsply Intl., York PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062828 is the FDA 510(k) clearance record for MOUTHGUARD AND ALIGNER MATERIALS, cleared for Dentsply Intl., Inc. on under FDA product code MQC (Mouthguard, Prescription). FDA records list 291 510(k) clearances for Dentsply Intl., Inc., from to . As of , FDA records show no recalls naming K062828.

Clearance record

Decision date
Received
(68 days to decision)
Product code
MQC Mouthguard, Prescription
Device class
Unclassified
Review panel
Unknown
Applicant
Dentsply Intl., Inc. Susquehanna Commerce Center, York PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQC

Trailing 12 months
2 clearances under product code MQC in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MQC, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260