510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K122025Substantially Equivalent

Brightglass Brightglass M

Ktk Medical Supplies GmbH, Germering, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122025 is the FDA 510(k) clearance record for BRIGHTGLASS BRIGHTGLASS M, a class II device, cleared for Ktk Medical Supplies GmbH on under FDA product code EBG (Crown And Bridge, Temporary, Resin). FDA records list one 510(k) clearance for Ktk Medical Supplies GmbH. As of , FDA records show no recalls naming K122025.

Clearance record

Decision date
Received
(90 days to decision)
Product code
EBG Crown And Bridge, Temporary, Resin
Regulation
21 CFR 872.3770
Device class
Class II
Review panel
Dental
Applicant
Ktk Medical Supplies GmbH Industriestr. 16, Germering, DE
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