Cleared Traditional

K992854 - ARTIFICIAL TEETH (ACRYLIC TEETH)

K992854 is an FDA 510(k) clearance for ARTIFICIAL TEETH (ACRYLIC TEETH), manufactured by Masterdent Ltda.. The device is a Class 2 Dental device with product code ELM cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K992854 · Masterdent Ltda. · Dental device
Download Printable Device Report (PDF)
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Feb 2000
Decision
167d
Days
Class 2
Risk

K992854 is an FDA 510(k) clearance for the ARTIFICIAL TEETH (ACRYLIC TEETH). Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by Masterdent Ltda. (Miami, US). The FDA issued a Cleared decision on February 7, 2000 after a review of 167 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Masterdent Ltda. devices

FDA 510(k) Submission Details - K992854

510(k) Number K992854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1999
Decision Date February 07, 2000
Days to Decision 167 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
40d slower than avg
Panel avg: 127d · This submission: 167d
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 27
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K992854.
SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER
K023035 · Ivoclar Vivadent, Inc. · Dec 2002
PREMIUM
K011130 · Heraeus Kulzer, Inc. · Jul 2001
WILLI GELLER CREAPEARL
K010160 · Jensen Industries, Inc. · Mar 2001
NATURA DENTURE TEETH
K984134 · Davis Schottlander & Davis, Ltd. · Feb 1999
ENIGMA DENTURE TEETH
K984128 · Davis Schottlander & Davis, Ltd. · Feb 1999
SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH
K962456 · Ivoclar North America, Inc. · Aug 1996