Cleared Traditional

K962065 - 3M VITREBOND LIGHT CURE GLASS IONOMER/BASE

K962065 is the FDA 510(k) clearance for 3M VITREBOND LIGHT CURE GLASS IONOMER/BASE by 3M Company. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K962065 · 3M Company · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
51d
Days
Class 2
Risk

K962065 is an FDA 510(k) clearance for the 3M VITREBOND LIGHT CURE GLASS IONOMER/BASE. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on July 18, 1996 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 3M Company devices

Submission Details

510(k) Number K962065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1996
Decision Date July 18, 1996
Days to Decision 51 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
76d faster than avg
Panel avg: 127d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 254
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K962065.
PULPDENT ENDODONTIC POST CEMENT KIT
K962747 · Pulpdent Corp. · Sep 1996
STERI-OSS TEMPORARY IMPLANT CEMENT
K963078 · Steri-Oss, Inc. · Sep 1996
PULPDENT RESILUTE II
K962383 · Pulpdent Corp. · Sep 1996
FUJI IX GP
K961448 · GC America, Inc. · Jul 1996
VIVAGLASS FIL
K961910 · Ivoclar North America, Inc. · Jun 1996
VIVAGLASS CEM
K962297 · Ivoclar North America, Inc. · Jun 1996