510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K260082Substantially Equivalent

TRIOS Dx (R1)

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

K260082 is the FDA 510(k) clearance record for TRIOS Dx (R1), a class II device, cleared for 3Shape TRIOS A/S on under FDA product code SHQ (Dental Image Analyzer, In-Office). FDA's definition for product code SHQ reads: "A dental image analyzer for in-office use is a prescription device that uses software intended to collect and analyze patient-specific, optical camera-based, intraoral images to be used by dental health care professionals as an aid to...". FDA records list 3 510(k) clearances for 3Shape TRIOS A/S, from to . As of , FDA records show no recalls naming K260082.

Clearance record

Decision date
Received
(88 days to decision)
Product code
SHQ Dental Image Analyzer, In-Office
Regulation
21 CFR 872.1770
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 SHQ

Trailing 12 months
1 clearance under product code SHQ 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 SHQ, 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