510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K032562Substantially Equivalent

Proceara Copings and Pontic

Nobel Biocare AB, Yorba Linda CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032562 is the FDA 510(k) clearance record for PROCEARA COPINGS AND PONTIC, a class II device, cleared for Nobel Biocare AB on under FDA product code ELL (Teeth, Porcelain). FDA records list 95 510(k) clearances for Nobel Biocare AB, from to . As of , FDA records show no recalls naming K032562.

Clearance record

Decision date
Received
(170 days to decision)
Product code
ELL Teeth, Porcelain
Regulation
21 CFR 872.3920
Device class
Class II
Review panel
Dental
Applicant
Nobel Biocare AB 22725 Savi Ranch Pkwy., Yorba Linda CA
510(k) summary
Summary PDF
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ELL, 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