510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K915276Substantially Equivalent

Denture Plastic Teeth,76 Elm

Nobelpharma USA, Inc., Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915276 is the FDA 510(k) clearance record for DENTURE PLASTIC TEETH,76 ELM, a class II device, cleared for Nobelpharma USA, Inc. on under FDA product code ELM (Denture, Plastic, Teeth). FDA records list 64 510(k) clearances for Nobelpharma USA, Inc., from to . As of , FDA records show no recalls naming K915276.

Clearance record

Decision date
Received
(70 days to decision)
Product code
ELM Denture, Plastic, Teeth
Regulation
21 CFR 872.3590
Device class
Class II
Review panel
Dental
Applicant
Nobelpharma USA, Inc. 5101 S. Keeler Ave., Chicago IL
510(k) summary
Statement
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ELM, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260