Cleared Traditional

K992985 - GLUMA COMFORT BOND

K992985 is an FDA 510(k) clearance for GLUMA COMFORT BOND, manufactured by Heraeus Kulzer, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K992985 · Heraeus Kulzer, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
41d
Days
Class 2
Risk

K992985 is an FDA 510(k) clearance for the GLUMA COMFORT BOND. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on October 14, 1999 after a review of 41 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 Heraeus Kulzer, Inc. devices

FDA 510(k) Submission Details - K992985

510(k) Number K992985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1999
Decision Date October 14, 1999
Days to Decision 41 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
86d faster than avg
Panel avg: 127d · This submission: 41d
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 317
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K992985.
BOND 1 C & B
K994359 · Jeneric/Pentron, Inc. · Mar 2000
RESIN TOOTH BONDING AGENT
K994302 · Parkell, Inc. · Feb 2000
PULPDENT UNO-DUO
K993683 · Pulpdent Corp. · Dec 1999
GLUMA COMFORT BOND + DESENSITIZER
K992292 · Heraeus Kulzer, Inc. · Oct 1999
MODIFICATION OF PROMPT L-POP
K992048 · Espe Dental AG · Aug 1999
OPTIBOND SOLO PLUS 2
K991808 · Sybron Dental Specialties, Inc. · Jul 1999