Cleared Traditional

K955070 - OPTIBOND

Also marketed or referenced as:
OPTIAID, OPTIREP, OPTISHINE, OPTICHROMA, OPTIFARB & OPTIWAK

K955070 is an FDA 510(k) clearance for OPTIBOND, manufactured by Optimal Dental (Usa). The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K955070 · Optimal Dental (Usa) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
35d
Days
Class 2
Risk

K955070 is an FDA 510(k) clearance for the OPTIBOND. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Optimal Dental (Usa) (Chicago, US). The FDA issued a Cleared decision on December 11, 1995 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Optimal Dental (Usa) devices

FDA 510(k) Submission Details - K955070

510(k) Number K955070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1995
Decision Date December 11, 1995
Days to Decision 35 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 127d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EIH Device Classification - Class 2, Special Controls

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 448
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K955070.
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ULTRADENT PORCELAIN ETCH
K951582 · Ultradent Products, Inc. · May 1995
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K951183 · Vident · May 1995