510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K903907Substantially Equivalent

Proceram Porcelain

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

K903907 is the FDA 510(k) clearance record for PROCERAM PORCELAIN, a class II device, cleared for Nobelpharma USA, Inc. on under FDA product code ELL (Teeth, Porcelain). FDA records list 64 510(k) clearances for Nobelpharma USA, Inc., from to . As of , FDA records show no recalls naming K903907.

Clearance record

Decision date
Received
(78 days to decision)
Product code
ELL Teeth, Porcelain
Regulation
21 CFR 872.3920
Device class
Class II
Review panel
Dental
Applicant
Nobelpharma USA, Inc. 5101 S. Keeler Ave., Chicago IL
Third party review
No

Clearances, product code ELL

Trailing 12 months

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

FDA records show no clearances under product code ELL in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ELL, 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