510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K100512Substantially Equivalent

Nobelprocera Ips E.max Crown

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

K100512 is the FDA 510(k) clearance record for NOBELPROCERA IPS E.MAX CROWN, a class II device, cleared for Nobel Biocare AB on under FDA product code EIH (Powder, Porcelain). FDA records list 95 510(k) clearances for Nobel Biocare AB, from to . As of , FDA records show no recalls naming K100512.

Clearance record

Decision date
Received
(179 days to decision)
Product code
EIH Powder, Porcelain
Regulation
21 CFR 872.6660
Device class
Class II
Review panel
Dental
Applicant
Nobel Biocare AB 22715 Savi Ranch Pkwy., Yorba Linda, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EIH

Trailing 12 months
15 clearances under product code EIH in the twelve months to November 2026, June 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EIH, trailing twelve months
MonthClearances
December 20251
January 20262
February 20260
March 20262
April 20261
May 20261
June 20263
July 20262
August 20261
September 20260
October 20262
November 20260