510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K153534Substantially Equivalent

NobelProcera HT ML Full Contour Zirconia Crown

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

K153534 is the FDA 510(k) clearance record for NobelProcera HT ML Full Contour Zirconia Crown, 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 K153534.

Clearance record

Decision date
Received
(180 days to decision)
Product code
ELL Teeth, Porcelain
Regulation
21 CFR 872.3920
Device class
Class II
Review panel
Dental
Applicant
Nobel Biocare AB Box 5190, Se-402 26, Vastra Hamnagatan 1, Goteborg, SE
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