Product Code: ELM
FDA class 2
21 CFR 872.3590
Denture, Plastic, Teeth
Dental
Denture Plastic Teeth are acrylic resin artificial teeth used in complete and removable partial dentures to replace missing natural teeth, chosen for their ease of processing, adjustability, and ability to bond chemically to acrylic denture base materials. They are classified as FDA Class 2 (moderate risk), requiring 510(k) premarket clearance. The product code is ELM, regulated under 21 CFR 872.3590 in the Dental (DE) specialty.
510(k)s
55
FEI Numbers
111
Registration Numbers
111
Unique Applicants
42
Years Active
36
Basic Information
- Product Code
- ELM
- Device Class
- FDA class 2
- Regulation Number
- 872.3590
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 55 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K132984 | SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S | Jan 14, 2014 | Substantially Equivalent | IVOCLAR VIVADENT, INC. |
| K122955 | DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM | Mar 01, 2013 | Substantially Equivalent | WRIGHT HEALTH GROUP LTD. |
| K122925 | NEW STETIC ARTIFICIAL TEETH | Feb 12, 2013 | Substantially Equivalent | NEW STETIC |
| K122852 | PHYSIOSTAR NFC | Dec 06, 2012 | Substantially Equivalent | CANDULOR USA, INC. |
| K121749 | VERACIA | Sep 07, 2012 | Substantially Equivalent | SHOFU DENTAL CORPORATION |
| K120404 | MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH | May 21, 2012 | Substantially Equivalent | MERZ DENTAL GMBH |
| K120736 | SR PHONARES II | May 14, 2012 | Substantially Equivalent | IVOCLAR VIVADENT AG |
| K113426 | VERACIA SA | Feb 08, 2012 | Substantially Equivalent | SHOFU DENTAL CORPORATION |
| K101064 | BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P | Sep 14, 2010 | Substantially Equivalent | BREDENT GMBH & CO.KG |
| K101029 | KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH | Aug 16, 2010 | Substantially Equivalent | HUGE DENTAL MATERIAL CO., LTD. |
| K093331 | SR PHONARES NHC | Jan 28, 2010 | Substantially Equivalent | IVOCLAR VIVADENT, INC. |
| K092231 | GEBDI TRIBOS 501 | Nov 24, 2009 | Substantially Equivalent | GEBDI DENTAL-PRODUCTS GMBH |
| K070591 | REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH | May 11, 2007 | Substantially Equivalent | UNION DENTAL S.A./UNIDESA.ODI |
| K060720 | CURATIVE DENTAL ACRYLIC TEETH | Aug 25, 2006 | Substantially Equivalent | CURATIVE, LLC |
| K061337 | WIEDENT ESTETIC | Jun 07, 2006 | Substantially Equivalent | XPDENT CORP. |
| K060994 | MONDIAL | May 22, 2006 | Substantially Equivalent | HERAEUS KULZER, INC. |
| K060565 | CONDYLAFORM II NFC | May 08, 2006 | Substantially Equivalent | IVOCLAR VIVADENT, INC. |
| K060507 | VALPLAST YAMAHACHI TEETH | Apr 07, 2006 | Substantially Equivalent | VALPLAST INTL. CORP. |
| K033628 | ARTIC | Jan 16, 2004 | Substantially Equivalent | HERAEUS KULZER, INC. |
| K030588 | ARTEGRAL AND POLYSTAR SELECTION | May 07, 2003 | Substantially Equivalent | MERZ DENTAL GMBH |
| K023035 | SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER | Dec 02, 2002 | Substantially Equivalent | IVOCLAR VIVADENT, INC. |
| K022299 | TRILUX, Z-TONE, ACRY ROCK | Oct 07, 2002 | Substantially Equivalent | RUTHIBRAS IMP. EXP. COM. DE MATERIAIS ODONTOLOGICO |
| K022300 | ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V | Oct 03, 2002 | Substantially Equivalent | DENTAL VIPI LTDA |
| K013824 | ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TONE PREFORMED PLASTIC DENTURE TEETH | Jan 30, 2002 | Substantially Equivalent | DENTAL MANUFACTURING S.P.A |
| K011130 | PREMIUM | Jul 05, 2001 | Substantially Equivalent | HERAEUS KULZER, INC. |
| K010160 | WILLI GELLER CREAPEARL | Mar 27, 2001 | Substantially Equivalent | JENSEN INDUSTRIES, INC. |
| K000213 | JELDENT BASIC LINE | Apr 06, 2000 | Substantially Equivalent | J.F. JELENKO & CO. |
| K992854 | ARTIFICIAL TEETH (ACRYLIC TEETH) | Feb 07, 2000 | Substantially Equivalent | MASTERDENT LTDA. |
| K984134 | NATURA DENTURE TEETH | Feb 12, 1999 | Substantially Equivalent | DAVIS SCHOTTLANDER & DAVIS, LTD. |
| K984128 | ENIGMA DENTURE TEETH | Feb 09, 1999 | Substantially Equivalent | DAVIS SCHOTTLANDER & DAVIS, LTD. |
| K962456 | SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH | Aug 06, 1996 | Substantially Equivalent | IVOCLAR NORTH AMERICA, INC. |
| K933737 | DURODENT CORPORATION ARTIFICIAL PLASTIC TEETH | Jun 13, 1994 | Substantially Equivalent | DURODENT CORP. |
| K936058 | OPTODENT/OPTOGNATH | May 16, 1994 | Substantially Equivalent | SPECTRUM HEALTHCARE GROUP |
| K940244 | VERIDENT PLUS, OPTIFORM | May 02, 1994 | Substantially Equivalent | LACTONA CORP. |
| K926070 | PRIMODENT ACRYLIC TEETH | Feb 17, 1994 | Substantially Equivalent | I.T.C. ENT. |
| K913582 | COMPATIT R | Jun 24, 1993 | Substantially Equivalent | WILDE-USA, INC. |
| K931162 | KING-HUE, ROYAL CORAL, SUPER-C ARTIFICIAL TEETH | May 27, 1993 | Substantially Equivalent | KING DENTAL CORP. |
| K920684 | NEW TOOTH MATERIAL | Dec 23, 1992 | Substantially Equivalent | DENTSPLY INTL. |
| K924526 | DENTURE PLASTIC TEETH | Nov 04, 1992 | Substantially Equivalent | AUSTENAL, INC. |
| K914476 | VITAPAN ACRYLIC DENTURE TEETH | Mar 02, 1992 | Substantially Equivalent | VIDENT |
| K915276 | DENTURE PLASTIC TEETH,76 ELM | Feb 03, 1992 | Substantially Equivalent | NOBELPHARMA USA, INC. |
| K871160 | TRUETECH MEDICAL, INC. DENTURE CUPS | Jun 23, 1987 | Substantially Equivalent | ZENEX MEDICAL, INC. |
| K864707 | SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH | Feb 10, 1987 | Substantially Equivalent | IVOCLAR USA, INC. |
| K853160 | AUSTENAL MODIFIED ACRYLIC DENTURE RESIN | Oct 31, 1985 | Substantially Equivalent | AUSTENAL DENTAL, INC. |
| K852981 | PREFORMED TOOTH ARCH | Aug 16, 1985 | Substantially Equivalent | SWIPES DENTAL LABORATORY |
| K844670 | KORVIN VITA RADIOPAQUE PLASTIC TEETH | Apr 08, 1985 | Substantially Equivalent | CREDENT CO. |
| K844349 | SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS | Dec 03, 1984 | Substantially Equivalent | IVOCLAR USA, INC. |
| K842208 | NATURA-TONE OR LUXOPAL CL ACRYLIC | Jul 31, 1984 | Substantially Equivalent | PAREXEL INTL. CORP. |
| K831214 | DELTA TEETH | May 09, 1983 | Substantially Equivalent | DENTSPLY INTL. |
| K810970 | ISOSIT TEETH | May 05, 1981 | Substantially Equivalent | BAUER, CHENG & ASSOCIATES, INC. |
| K802492 | REIGNING ARTIFICIAL TEETH | Nov 12, 1980 | Substantially Equivalent | OKI SHIKS USA LTD. |
| K801235 | REIGNING ARTIFICIAL TEETH/POLYCARB.RESIN | Jun 20, 1980 | Substantially Equivalent | OKI SHIKS USA LTD. |
| K792245 | TEETH, DENTURE, PLASTIC | Jan 04, 1980 | Substantially Equivalent | DENTSPLY INTL. |
| K780217 | ANTERIORS AND POSTERIORS, PLASTIC | Mar 15, 1978 | Substantially Equivalent | DENTSPLY INTL. |
| K771398 | SHELL VENEER | Aug 26, 1977 | Substantially Equivalent | L.D. CAULK CO. |
FEI Numbers
This FDA classification entry is associated with 111 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 111 registration numbers. Click on an entry to view related FDA registrations.