510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K031070Substantially Equivalent

Carbon Fiber Bridge, Model 28757

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

K031070 is the FDA 510(k) clearance record for CARBON FIBER BRIDGE, MODEL 28757, a class II device, cleared for Nobel Biocare AB on under FDA product code EBI (Resin, Denture, Relining, Repairing, Rebasing). FDA records list 95 510(k) clearances for Nobel Biocare AB, from to . As of , FDA records show no recalls naming K031070.

Clearance record

Decision date
Received
(90 days to decision)
Product code
EBI Resin, Denture, Relining, Repairing, Rebasing
Regulation
21 CFR 872.3760
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 EBI

Trailing 12 months
7 clearances under product code EBI in the twelve months to November 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EBI, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20263
August 20262
September 20260
October 20260
November 20260