Cleared Traditional

K001876 - TAKE 1 BITE

K001876 is an FDA 510(k) clearance for TAKE 1 BITE, manufactured by Sybron Dental Specialties, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K001876 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
31d
Days
Class 2
Risk

K001876 is an FDA 510(k) clearance for the TAKE 1 BITE. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on July 21, 2000 after a review of 31 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.

FDA 510(k) Submission Details - K001876

510(k) Number K001876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2000
Decision Date July 21, 2000
Days to Decision 31 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
97d faster than avg
Panel avg: 128d · This submission: 31d
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 391
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K001876.
ALGINATE IMPRESSION MATERIAL
K003426 · Rite-Dent Manufacturing Corp. · Jan 2001
PERMLASTIC 2
K001655 · Kerr Corp. · Aug 2000
KWIKKMODEL
K001414 · R-Dental Dentalerzeugnisse GmbH · Aug 2000
CORRECT PLUS
K001218 · Jeneric/Pentron, Inc. · Jul 2000
KROM-ALGINATE AND ALGINATE PLUS
K000686 · Cavex Holland BV · May 2000
ACTIVATOR PASTE
K994027 · Harry J. Bosworth Co. · Apr 2000
K001876 · TAKE 1 BITE
Download PDF FDA Summary Sybron Dental Special…