Cleared Traditional

K992838 - ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE

K992838 is an FDA 510(k) clearance for ADHERE CONDITIONER, manufactured by Biomat Sciences, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K992838 · Biomat Sciences, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
84d
Days
Class 2
Risk

K992838 is an FDA 510(k) clearance for the ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC AC.... Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Biomat Sciences, Inc. (Bethesda, US). The FDA issued a Cleared decision on November 15, 1999 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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 Biomat Sciences, Inc. devices

FDA 510(k) Submission Details - K992838

510(k) Number K992838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1999
Decision Date November 15, 1999
Days to Decision 84 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
43d faster than avg
Panel avg: 127d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLE Device Classification - Class 2, Special Controls

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 374
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K992838.
TOKUYAMA ONE-UP-BOND F
K993917 · Tokuyama America, Inc. · Feb 2000
PULPDENT UNO-DUO
K993683 · Pulpdent Corp. · Dec 1999
SURE BOND
K993013 · Miradent Distributing Co., LLC · Nov 1999
ECUSIT COMPOSITE REPAIR
K992879 · Dmg Hamburg · Nov 1999
GLUMA COMFORT BOND
K992985 · Heraeus Kulzer, Inc. · Oct 1999
GLUMA COMFORT BOND + DESENSITIZER
K992292 · Heraeus Kulzer, Inc. · Oct 1999