Cleared Traditional

K981036 - SMARTBOND

K981036 is an FDA 510(k) clearance for SMARTBOND, manufactured by Gac Intl., Inc.. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 382-day FDA review.

K981036 · Gac Intl., Inc. · Dental device
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Apr 1999
Decision
382d
Days
Class 2
Risk

K981036 is an FDA 510(k) clearance for the SMARTBOND. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Gac Intl., Inc. (Central Islip, US). The FDA issued a Cleared decision on April 5, 1999 after a review of 382 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3750 - 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. Elevated predicate reliance profile. 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 Gac Intl., Inc. devices

FDA 510(k) Submission Details - K981036

510(k) Number K981036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1998
Decision Date April 05, 1999
Days to Decision 382 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
255d slower than avg
Panel avg: 127d · This submission: 382d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYH Device Classification - Class 2, Special Controls

Product Code DYH Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3750
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 - DYH Adhesive, Bracket And Tooth Conditioner, Resin

All 148
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K981036.
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ENLIGHT LV
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ENLIGHT-2
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