Cleared Traditional

K060720 - CURATIVE DENTAL ACRYLIC TEETH

K060720 is an FDA 510(k) clearance for CURATIVE DENTAL ACRYLIC TEETH, manufactured by Curative, LLC. The device is a Class 2 Dental device with product code ELM cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K060720 · Curative, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
161d
Days
Class 2
Risk

K060720 is an FDA 510(k) clearance for the CURATIVE DENTAL ACRYLIC TEETH. Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by Curative, LLC (North Attleboro, US). The FDA issued a Cleared decision on August 25, 2006 after a review of 161 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.

FDA 510(k) Submission Details - K060720

510(k) Number K060720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2006
Decision Date August 25, 2006
Days to Decision 161 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
33d slower than avg
Panel avg: 128d · This submission: 161d
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 48
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K060720.
SR PHONARES NHC
K093331 · Ivoclar Vivadent, Inc. · Jan 2010
GEBDI TRIBOS 501
K092231 · Gebdi Dental-Products GmbH · Nov 2009
REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH
K070591 · Union Dental S.A./Unidesa.Odi · May 2007
WIEDENT ESTETIC
K061337 · Xpdent Corp · Jun 2006
MONDIAL
K060994 · Heraeus Kulzer, Inc. · May 2006
CONDYLAFORM II NFC
K060565 · Ivoclar Vivadent, Inc. · May 2006
K060720 · CURATIVE DENTAL ACRYLIC TEETH
Download PDF FDA Summary Curative, LLC