Cleared Traditional

K031070 - CARBON FIBER BRIDGE, MODEL 28757

K031070 is an FDA 510(k) clearance for CARBON FIBER BRIDGE, manufactured by Nobel Biocare AB. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K031070 · Nobel Biocare AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
90d
Days
Class 2
Risk

K031070 is an FDA 510(k) clearance for the CARBON FIBER BRIDGE, MODEL 28757. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Nobel Biocare AB (Yorba Linda, US). The FDA issued a Cleared decision on July 3, 2003 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Nobel Biocare AB devices

FDA 510(k) Submission Details - K031070

510(k) Number K031070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2003
Decision Date July 03, 2003
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EBI Resin, Denture, Relining, Repairing, Rebasing

All 239
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K031070.
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K033629 · Heraeus Kulzer, Inc. · Dec 2003
MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM
K032892 · Dentsply Intl. · Sep 2003
UFI GEL HARD C
K030916 · Voco GmbH · Jun 2003
TOKUYAMA SOFRELINER TOUGH
K030663 · Tokuyama Dental Corporation · May 2003
TOKUYAMA REBASE II
K022641 · Tokuyama America, Inc. · Oct 2002