Cleared Traditional

K000211 - BUILD-IT FR

K000211 is an FDA 510(k) clearance for BUILD-IT FR, manufactured by Jeneric/Pentron, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K000211 · Jeneric/Pentron, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
53d
Days
Class 2
Risk

K000211 is an FDA 510(k) clearance for the BUILD-IT FR. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on March 17, 2000 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Jeneric/Pentron, Inc. devices

FDA 510(k) Submission Details - K000211

510(k) Number K000211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2000
Decision Date March 17, 2000
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.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 645
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K000211.
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K000530 · Sybron Dental Specialties, Inc. · May 2000
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K000436 · Sybron Dental Specialties, Inc. · Mar 2000
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K000269 · Sybron Dental Specialties, Inc. · Mar 2000
ARABESK FLOW
K994304 · Voco GmbH · Feb 2000
ARABESK TOP
K994268 · Voco GmbH · Feb 2000
RENAMEL SCULPT
K993658 · Cosmedent, Inc. · Jan 2000