Cleared Traditional

K010800 - VERSYO.COM

K010800 is the FDA 510(k) clearance for VERSYO.COM by Heraeus Kulzer, Inc.. It is a Class 2 Dental device (product code EBI) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K010800 · Heraeus Kulzer, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
76d
Days
Class 2
Risk

K010800 is an FDA 510(k) clearance for the VERSYO.COM. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Armonk, US). The FDA issued a Cleared decision on May 31, 2001 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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

Submission Details

510(k) Number K010800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2001
Decision Date May 31, 2001
Days to Decision 76 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
51d faster than avg
Panel avg: 127d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 152
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K010800.
SECURE SOFT
K021437 · Imtec Corp. · Jul 2002
SECURE RELINE/PICKUP MATERIAL
K021586 · Imtec Corp. · Jun 2002
TRUBYTE DENTURE BASE RESIN SYSTEM
K011560 · Dentsply Intl. · Jul 2001
UFI GEL HARD
K993827 · Voco GmbH · Jan 2000
LUCITONE FRS FLEXIBEL DENTAL RESIN
K992956 · Dentsply Intl. · Oct 1999
ACRON MC MODIFICATION
K991774 · GC America, Inc. · Jul 1999