Search Results
Found 31 results
510(k) Data Aggregation
K Number
K132984Device Name
SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2014-01-14
(112 days)
Product Code
ELM
Regulation Number
872.3590Why did this record match?
Product Code :
ELM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Preformed denture teeth used for total and partial dentures and implant-supported removable prostheses.
Device Description
Preformed denture teeth used for total and partial dentures and implant-supported removable prostheses.
Ask a Question
K Number
K122955Device Name
DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM
Manufacturer
WRIGHT HEALTH GROUP LTD.
Date Cleared
2013-03-01
(157 days)
Product Code
ELM
Regulation Number
872.3590Why did this record match?
Product Code :
ELM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These dental plastic teeth are parts used for denture fabrication. PMMA is mixed with monomer in a polymenzation process. The plastic teeth are part of dentures made to fit a patient's mouth which are removable or may be attached to dental implant devices.
Device Description
The synthetic plastic teeth are used in the production of dentures. They are produced from a I he synuletic process. Polymethylmethacrylate or PMMA is mixed with methylmethacrylate monomer, a cross linking agent and non-toxic pigments under heat and pressure. Once the monomer, a cross iniking agoit and non teen are checked for flash and polished according to the relevant model characteristics.
Ask a Question
K Number
K122925Device Name
NEW STETIC ARTIFICIAL TEETH
Manufacturer
NEW STETIC
Date Cleared
2013-02-12
(141 days)
Product Code
ELM, INT
Regulation Number
872.3590Why did this record match?
Product Code :
ELM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
The New Stetic Acrylic Teeth are made of acrylic resin; the teeth come in various shades and sizes to fit the requirements of the specific patient.
Ask a Question
K Number
K122852Device Name
PHYSIOSTAR NFC
Manufacturer
CANDULOR USA, INC.
Date Cleared
2012-12-06
(79 days)
Product Code
ELM
Regulation Number
872.3590Why did this record match?
Product Code :
ELM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Physiostar NFC denture teeth are intended to be used for complete and partial denture r nyslostar NF & dontare tooling and implant-supported dentures.
Device Description
Not Found
Ask a Question
K Number
K121749Device Name
VERACIA
Manufacturer
SHOFU DENTAL CORPORATION
Date Cleared
2012-09-07
(85 days)
Product Code
ELM
Regulation Number
872.3590Why did this record match?
Product Code :
ELM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Used as artificial teeth to produce partial and full dentures.
Device Description
Not Found
Ask a Question
K Number
K120404Device Name
MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH
Manufacturer
MERZ DENTAL GMBH
Date Cleared
2012-05-21
(102 days)
Product Code
ELM
Regulation Number
872.3590Why did this record match?
Product Code :
ELM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Artegral HD are posterior preformed plastic denture teeth for use in:
- supra construction for combined, fixed removable dental prostheses .
- hybrid construction for implant-supported dental prostheses .
- cover denture .
- total prostheses .
- model cast prostheses ●
- . partial dentures
Device Description
artegral HD are preformed posterior plastic teeth made from an Interpenetrated Network (IPN) of polymethylmethacrylate (PMMA) with two finer Networks. The tooth neck is made from Organic Modified Polymer Network (OMP-N) and the incisal and dentine portions of the tooth are made from Highly Modified Polymer-Network (HMP-N). OMP-N has added insoluble PMMA spheres, and HMP-N has added amorphous silicon dioxide nanoparticles and fluorapatite. The artegral HD teeth comply with all the requirement of ISO 22112:2005 Dentistry - Artificial teeth for dental prostheses. The additives in artegral HD teeth are known biocompatible materials.
Ask a Question
K Number
K120736Device Name
SR PHONARES II
Manufacturer
IVOCLAR VIVADENT AG
Date Cleared
2012-05-14
(66 days)
Product Code
ELM
Regulation Number
872.3590Why did this record match?
Product Code :
ELM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SR Phonares II denture teeth are intended to be used for complete and partial denture prosthetics including hybrid dentures and implant-supported dentures.
Device Description
Not Found
Ask a Question
K Number
K113426Device Name
VERACIA SA
Manufacturer
SHOFU DENTAL CORPORATION
Date Cleared
2012-02-08
(82 days)
Product Code
ELM
Regulation Number
872.3590Why did this record match?
Product Code :
ELM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Used as artificial teeth to produce partial and full dentures.
Device Description
Not Found
Ask a Question
K Number
K101064Device Name
BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P
Manufacturer
BREDENT GMBH & CO.KG
Date Cleared
2010-09-14
(151 days)
Product Code
ELM
Regulation Number
872.3590Why did this record match?
Product Code :
ELM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The bredent novo.lign A / novo.lign P are preformed plastic denture teeth as a prefabricated device, composed of materials such as polymethylmethacrylat and methylmethacrylat that are intended for use as veneers. The bredent novo:lign P are used for temporary or partial or full dentures.
Permanent veneering:
- telescopic and conical crowns
- CoCr clasp restorations
- crowns and bridges
- implant-supported restorations
- coverdenture techniques
Veneer-up:
- selection of esthetic shade, shape and tooth position
Temporary restorations:
- laboratory-made temporaries based on impression and wax-up
- veneer on temporary abutments after placement of the implant
The devices are offered in non-sterile condition.
Device Description
Bredent novo.lign A / novo.lign P artificial are multi-layer veneers for anterior and posterior teeth. Theses teeth devices are chemically based on polymethacrylate-polymers and their chemical properties. These reformed plastic dentures are used when fabricating any kind of dental restauration (see application range beneath).
Ask a Question
K Number
K101029Device Name
KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH
Manufacturer
HUGE DENTAL MATERIAL CO., LTD.
Date Cleared
2010-08-16
(125 days)
Product Code
ELM
Regulation Number
872.3590Why did this record match?
Product Code :
ELM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is intended for use as a tooth in a denture.
These teeth are used for making full or partial dentures. The artificial resin teeth are mounted on an appliance made of dental acrylic resin. The appliance is made to fit the patient's mouth and is a removable. It is not implanted.
Device Description
The Synthetic Polymer Teeth (Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, MAIST and Kaitong/Royal) used in the production of dentures are produced through a dough molding process. Polymethylmethacrylate (PMMA) is mixed with methylmethacrylate monomer and a crosslinking agent.
Once the polymerization process has been carried out, the teeth are obtained and the next step is to remove any burrs and polish them.
Ask a Question
Page 1 of 4