510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K210011Substantially Equivalent

JS Dental Lab Mouth Guard

Ampower Dental Laboratories, LLC, Hayward CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210011 is the FDA 510(k) clearance record for JS Dental Lab Mouth Guard, cleared for Ampower Dental Laboratories, LLC on under FDA product code MQC (Mouthguard, Prescription). FDA records list one 510(k) clearance for Ampower Dental Laboratories, LLC. As of , FDA records show no recalls naming K210011.

Clearance record

Decision date
Received
(193 days to decision)
Product code
MQC Mouthguard, Prescription
Device class
Unclassified
Review panel
Unknown
Applicant
Ampower Dental Laboratories, LLC 3423 Investment Blvd. Suite 11 Hayward, Hayward CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQC

Trailing 12 months
3 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 20261
October 20260