Cleared Traditional

K010160 - WILLI GELLER CREAPEARL

K010160 is an FDA 510(k) clearance for WILLI GELLER CREAPEARL, manufactured by Jensen Industries, Inc.. The device is a Class 2 Dental device with product code ELM cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K010160 · Jensen Industries, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
70d
Days
Class 2
Risk

K010160 is an FDA 510(k) clearance for the WILLI GELLER CREAPEARL. Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by Jensen Industries, Inc. (North Haven, US). The FDA issued a Cleared decision on March 27, 2001 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3590 - 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 - K010160

510(k) Number K010160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2001
Decision Date March 27, 2001
Days to Decision 70 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
58d faster than avg
Panel avg: 128d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELM Device Classification - Class 2, Special Controls

Product Code ELM Denture, Plastic, Teeth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3590
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 - ELM Denture, Plastic, Teeth

All 53
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K010160.
ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V
K022300 · Dental Vipi Ltda · Oct 2002
ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TONE PREFORMED PLASTIC DENTURE TEETH
K013824 · Dental Manufacturing S.P.A · Jan 2002
PREMIUM
K011130 · Heraeus Kulzer, Inc. · Jul 2001
JELDENT BASIC LINE
K000213 · J.F. Jelenko & Co. · Apr 2000
ARTIFICIAL TEETH (ACRYLIC TEETH)
K992854 · Masterdent Ltda. · Feb 2000
NATURA DENTURE TEETH
K984134 · Davis Schottlander & Davis, Ltd. · Feb 1999
K010160 · WILLI GELLER CREAPEARL
Download PDF FDA Summary Jensen Industries, In…