510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221249Substantially Equivalent

L1p-1F (Trios 5)

3SHAPE Trios a/S, Copenhagen, DK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221249 is the FDA 510(k) clearance record for L1P-1F (TRIOS 5), a class II device, cleared for 3Shape TRIOS A/S on under FDA product code NBL (Light-Induced Fluorescence Caries Detector). FDA records list 3 510(k) clearances for 3Shape TRIOS A/S, from to . As of , FDA records show no recalls naming K221249.

Clearance record

Decision date
Received
(137 days to decision)
Product code
NBL Light-Induced Fluorescence Caries Detector
Regulation
21 CFR 872.1745
Device class
Class II
Review panel
Dental
Applicant
3Shape TRIOS A/S Holmens Kanal 7, Copenhagen, DK
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NBL

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