510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K852981Substantially Equivalent

Preformed Tooth Arch

Swipes Dental Laboratory, Harrisburg PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852981 is the FDA 510(k) clearance record for PREFORMED TOOTH ARCH, a class II device, cleared for Swipes Dental Laboratory on under FDA product code ELM (Denture, Plastic, Teeth). FDA records list one 510(k) clearance for Swipes Dental Laboratory. As of , FDA records show no recalls naming K852981.

Clearance record

Decision date
Received
(32 days to decision)
Product code
ELM Denture, Plastic, Teeth
Regulation
21 CFR 872.3590
Device class
Class II
Review panel
Dental
Applicant
Swipes Dental Laboratory P.O. Box 2061, Harrisburg PA
Third party review
No

Clearances, product code ELM

Trailing 12 months

FDA records hold no clearances under product code ELM in the trailing twelve months.

FDA records show no clearances under product code ELM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ELM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260