510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K021569Substantially Equivalent

Restful Nights, Ist-Appliance

Ottawa Dental Laboratory, Crofton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K021569 is the FDA 510(k) clearance record for RESTFUL NIGHTS, IST-APPLIANCE, a class II device, cleared for Ottawa Dental Laboratory on under FDA product code LRK (Device, Anti-Snoring). FDA records list one 510(k) clearance for Ottawa Dental Laboratory. As of , FDA records show no recalls naming K021569.

Clearance record

Decision date
Received
(671 days to decision)
Product code
LRK Device, Anti-Snoring
Regulation
21 CFR 872.5570
Device class
Class II
Review panel
Dental
Applicant
Ottawa Dental Laboratory P.O. Box 4341, Crofton MD
510(k) summary
Statement
Third party review
No

Clearances, product code LRK

Trailing 12 months
14 clearances under product code LRK in the twelve months to October 2026, November 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code LRK, trailing twelve months
MonthClearances
November 20253
December 20252
January 20260
February 20260
March 20262
April 20261
May 20261
June 20262
July 20261
August 20261
September 20260
October 20261