Cleared Traditional

K991425 - XANTOPREN COMFORT

K991425 is an FDA 510(k) clearance for XANTOPREN COMFORT, manufactured by Heraeus Kulzer, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K991425 · Heraeus Kulzer, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
53d
Days
Class 2
Risk

K991425 is an FDA 510(k) clearance for the XANTOPREN COMFORT. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on June 15, 1999 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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 - K991425

510(k) Number K991425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1999
Decision Date June 15, 1999
Days to Decision 53 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
74d faster than avg
Panel avg: 127d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 195
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K991425.
ALGINATE IMPRESSION MATERIAL I (FAST & REGULAR SET)
K991489 · Harry J. Bosworth Co. · Jul 1999
ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET)
K991490 · Harry J. Bosworth Co. · Jul 1999
DIMENSION BITE
K991008 · Espe Dental AG · Jun 1999
VESTOGUM
K991221 · Espe Dental AG · May 1999
1ST IMPRESSION
K983106 · Den-Mat Corp. · Feb 1999
B-SYSTEM SILICONE
K982917 · Sybron Dental Specialties, Inc. · Oct 1998