Cleared Traditional

K010800 - VERSYO.COM

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

K010800 · Heraeus Kulzer, Inc. · Dental device
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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

FDA 510(k) Submission Details - K010800

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.

EBI Device Classification - Class 2, Special Controls

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 259
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K010800.
SECURE RELINE/PICKUP MATERIAL
K021586 · Imtec Corp. · Jun 2002
TRUBYTE DENTURE BASE RESIN SYSTEM
K011560 · Dentsply Intl. · Jul 2001
HARD RELINER
K011277 · S & C Polymer GmbH · Jun 2001
EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL
K992176 · St. George Technology, Inc. · Feb 2000
UFI GEL HARD
K993827 · Voco GmbH · Jan 2000
ENIGMA HI-BASE DENTURE BASE MATERIAL
K993717 · Davis Schottlander & Davis, Ltd. · Dec 1999