Cleared Traditional

K011756 - ADMIRA FLOW

K011756 is an FDA 510(k) clearance for ADMIRA FLOW, manufactured by Voco GmbH. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K011756 · Voco GmbH · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
42d
Days
Class 2
Risk

K011756 is an FDA 510(k) clearance for the ADMIRA FLOW. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Voco GmbH (St Louis, US). The FDA issued a Cleared decision on July 18, 2001 after a review of 42 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.

FDA 510(k) Submission Details - K011756

510(k) Number K011756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2001
Decision Date July 18, 2001
Days to Decision 42 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 128d · This submission: 42d
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 934
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K011756.
LUXACORE/LUXACORE DUAL
K012307 · Dmg USA, Inc. · Aug 2001
CORERESTORE 2
K011798 · Sybron Dental Specialties, Inc. · Aug 2001
TOOTH SHADE RESIN MATERIAL
K011453 · Rite-Dent Manufacturing Corp. · Jul 2001
LUTE
K011517 · First Scientific Limited · Jul 2001
IN TEN-S
K011492 · Ivoclar North America, Inc. · Jul 2001
RESTORE-PF VIC
K011295 · First Scientific Limited · Jun 2001
K011756 · ADMIRA FLOW
Download PDF FDA Summary Voco GmbH