Cleared Traditional

K792003 - 1 STEP

K792003 is an FDA 510(k) clearance for 1 STEP, manufactured by Betta Dental, Inc.. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K792003 · Betta Dental, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1979
Decision
55d
Days
Class 2
Risk

K792003 is an FDA 510(k) clearance for the 1 STEP. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Betta Dental, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 27, 1979 after a review of 55 days - a notably fast clearance cycle.

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: 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 Betta Dental, Inc. devices

FDA 510(k) Submission Details - K792003

510(k) Number K792003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1979
Decision Date November 27, 1979
Days to Decision 55 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 128d · This submission: 55d
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 151
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K792003.
HELIOSIT-ORTHODONTIC
K823409 · Vivadent (Usa), Inc. · Jan 1983
ORTHODAPTIC* BONDING ADHESIVE
K823851 · Johnson & Johnson Professionals, Inc. · Jan 1983
INSTA-BOND
K810517 · Lee Pharmaceuticals · Mar 1981
SCI-PHARM ORTHODONTIC ADHESIVE
K791132 · Scientific Pharmaceuticals, Inc. · Aug 1979
SEAL & BOND DIRECT BONDING ORTHODONTIC
K790962 · Scientific Pharmaceuticals, Inc. · Jul 1979
ORTHODONTIC. PLASTIC BRACKET PRIMER
K780028 · 3M Company · Jan 1978