510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161884Substantially Equivalent

Ortho System

3Shape A/S, Copenhagen, DK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K161884 is the FDA 510(k) clearance record for Ortho System, cleared for 3Shape A/S on under FDA product code MQC (Mouthguard, Prescription). FDA records list 8 510(k) clearances for 3Shape A/S, from to . As of , FDA records show no recalls naming K161884.

Clearance record

Decision date
Received
(282 days to decision)
Product code
MQC Mouthguard, Prescription
Device class
Unclassified
Review panel
Unknown
Applicant
3Shape A/S Holmens Kanal 7, Copenhagen, DK
510(k) summary
Statement
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