Cleared Traditional

K993602 - PRE-VISION FILL

K993602 is an FDA 510(k) clearance for PRE-VISION FILL, manufactured by Heraeus Kulzer, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K993602 · Heraeus Kulzer, Inc. · Dental device
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Dec 1999
Decision
51d
Days
Class 2
Risk

K993602 is an FDA 510(k) clearance for the PRE-VISION FILL. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on December 15, 1999 after a review of 51 days - a notably fast clearance cycle.

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

FDA 510(k) Submission Details - K993602

510(k) Number K993602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1999
Decision Date December 15, 1999
Days to Decision 51 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
76d faster than avg
Panel avg: 127d · This submission: 51d
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 645
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K993602.
KETAC-MOLAR QUICK
K994251 · Espe Dental AG · Jan 2000
SOLITAIRE 2
K993932 · Heraeus Kulzer, Inc. · Dec 1999
PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE
K993716 · Harry J. Bosworth Co. · Dec 1999
TETRIC FLOW
K993783 · Ivoclar North America, Inc. · Dec 1999
PROMPTFLOW
K993566 · Espe Dental AG · Dec 1999
HYTAC
K992909 · Espe Dental AG · Nov 1999