Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3590](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3590) → ELM — Denture, Plastic, Teeth # ELM · Denture, Plastic, Teeth _Dental · 21 CFR 872.3590 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELM ## Overview - **Product Code:** ELM - **Device Name:** Denture, Plastic, Teeth - **Regulation:** [21 CFR 872.3590](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3590) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) ## 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](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELM/K132984.md) | SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S | Ivoclar Vivadent, Inc. | Jan 14, 2014 | SESE | | [K122955](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELM/K122955.md) | DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM | Wright Health Group , Ltd. | Mar 1, 2013 | SESE | | [K122925](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELM/K122925.md) | NEW STETIC ARTIFICIAL TEETH | New Stetic | Feb 12, 2013 | SESE | | [K122852](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELM/K122852.md) | PHYSIOSTAR NFC | Candulor USA, Inc. | Dec 6, 2012 | SESE | | [K121749](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELM/K121749.md) | VERACIA | Shofu Dental Corporation | Sep 7, 2012 | SESE | | [K120404](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELM/K120404.md) | MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH | Merz Dental GmbH | May 21, 2012 | SESE | | [K120736](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELM/K120736.md) | SR PHONARES II | Ivoclar Vivadent, AG | May 14, 2012 | SESE | | [K113426](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELM/K113426.md) | VERACIA SA | Shofu Dental Corporation | Feb 8, 2012 | SESE | | [K101064](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELM/K101064.md) | BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P | Bredent GmbH & Co. KG | Sep 14, 2010 | SESE | | [K101029](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELM/K101029.md) | KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH | Huge Dental Material Co., Ltd. | Aug 16, 2010 | SESE | | [K093331](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELM/K093331.md) | SR PHONARES NHC | Ivoclar Vivadent, Inc. | Jan 28, 2010 | SESE | | [K092231](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELM/K092231.md) | GEBDI TRIBOS 501 | Gebdi Dental-Products GmbH | Nov 24, 2009 | SESE | | [K070591](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELM/K070591.md) | REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH | Union Dental S.A./Unidesa.Odi | May 11, 2007 | SESE | | [K060720](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELM/K060720.md) | CURATIVE DENTAL ACRYLIC TEETH | Curative, LLC | Aug 25, 2006 | SESE | | [K061337](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELM/K061337.md) | WIEDENT ESTETIC | Xpdent Corp | Jun 7, 2006 | SESE | | [K060994](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELM/K060994.md) | MONDIAL | Heraeus Kulzer, Inc. | May 22, 2006 | SESE | | [K060565](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELM/K060565.md) | CONDYLAFORM II NFC | Ivoclar Vivadent, Inc. | May 8, 2006 | SESE | | [K060507](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELM/K060507.md) | VALPLAST YAMAHACHI TEETH | Valplast Intl. Corp. | Apr 7, 2006 | SESE | | [K033628](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELM/K033628.md) | ARTIC | Heraeus Kulzer, Inc. | Jan 16, 2004 | SESE | | [K030588](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELM/K030588.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELM](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELM) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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