ELM · Denture, Plastic, Teeth
Dental · 21 CFR 872.3590 · Class 2
Overview
| Product Code | ELM |
|---|---|
| Device Name | Denture, Plastic, Teeth |
| Regulation | 21 CFR 872.3590 |
| Device Class | Class 2 |
| Review Panel | Dental |
Identification
A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Recent Cleared Devices (20 of 55)
Showing 20 most recent of 55 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K132984 | SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S | Ivoclar Vivadent, Inc. | Jan 14, 2014 | SESE |
| K122955 | DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM | Wright Health Group , Ltd. | Mar 1, 2013 | SESE |
| K122925 | NEW STETIC ARTIFICIAL TEETH | New Stetic | Feb 12, 2013 | SESE |
| K122852 | PHYSIOSTAR NFC | Candulor USA, Inc. | Dec 6, 2012 | SESE |
| K121749 | VERACIA | Shofu Dental Corporation | Sep 7, 2012 | SESE |
| K120404 | MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH | Merz Dental GmbH | May 21, 2012 | SESE |
| K120736 | SR PHONARES II | Ivoclar Vivadent, AG | May 14, 2012 | SESE |
| K113426 | VERACIA SA | Shofu Dental Corporation | Feb 8, 2012 | SESE |
| K101064 | BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P | Bredent GmbH & Co. KG | Sep 14, 2010 | SESE |
| K101029 | KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH | Huge Dental Material Co., Ltd. | Aug 16, 2010 | SESE |
| K093331 | SR PHONARES NHC | Ivoclar Vivadent, Inc. | Jan 28, 2010 | SESE |
| K092231 | GEBDI TRIBOS 501 | Gebdi Dental-Products GmbH | Nov 24, 2009 | SESE |
| K070591 | REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH | Union Dental S.A./Unidesa.Odi | May 11, 2007 | SESE |
| K060720 | CURATIVE DENTAL ACRYLIC TEETH | Curative, LLC | Aug 25, 2006 | SESE |
| K061337 | WIEDENT ESTETIC | Xpdent Corp | Jun 7, 2006 | SESE |
| K060994 | MONDIAL | Heraeus Kulzer, Inc. | May 22, 2006 | SESE |
| K060565 | CONDYLAFORM II NFC | Ivoclar Vivadent, Inc. | May 8, 2006 | SESE |
| K060507 | VALPLAST YAMAHACHI TEETH | Valplast Intl. Corp. | Apr 7, 2006 | SESE |
| K033628 | ARTIC | Heraeus Kulzer, Inc. | Jan 16, 2004 | SESE |
| K030588 | ARTEGRAL AND POLYSTAR SELECTION | Merz Dental GmbH | May 7, 2003 | SESE |
Top Applicants
- Ivoclar Vivadent, Inc. — 4 clearances
- Dentsply Intl. — 4 clearances
- Heraeus Kulzer, Inc. — 3 clearances
- Shofu Dental Corporation — 2 clearances
- Oki Shiks USA , Ltd. — 2 clearances
