Cleared Traditional

K960729 - ENAMEL CONDITIONER (ENAMEL ETCHING AGENT)

K960729 is an FDA 510(k) clearance for ENAMEL CONDITIONER (ENAMEL ETCHING AGENT), manufactured by Dent Zar, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K960729 · Dent Zar, Inc. · Dental device
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Apr 1996
Decision
64d
Days
Class 2
Risk

K960729 is an FDA 510(k) clearance for the ENAMEL CONDITIONER (ENAMEL ETCHING AGENT). Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Dent Zar, Inc. (Tarzana, US). The FDA issued a Cleared decision on April 26, 1996 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Dent Zar, Inc. devices

FDA 510(k) Submission Details - K960729

510(k) Number K960729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1996
Decision Date April 26, 1996
Days to Decision 64 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
63d faster than avg
Panel avg: 127d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 761
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K960729.
CONCORD MARYLAND BRIDGE CEMENT
K960598 · Dent Zar, Inc. · Apr 1996
SUPERIOR PHOTOCURING HYBRID COMPOSITE
K960599 · Dent Zar, Inc. · Apr 1996
LEXUR ENAMEL COATING-PORCELAIN REPAIR-BONDING VENEERS
K960600 · Dent Zar, Inc. · Apr 1996
ACORN ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE
K960565 · Dent Zar, Inc. · Mar 1996
ALPHA-DENT COMPOSITE SURFACE SEALANT
K960165 · Wallace A. Erickson & Co. · Mar 1996
CRYSTALLESSENCE
K954988 · Confi-Dental Products Co. · Mar 1996