FDA.reportPublic FDA data

Duracetal 30pk

Primary DI
00842326103047
Brand
Duracetal 30pk
Company
The Myerson Company Limited
Model
SS-30pk
Device description
Variety Pack (30 Single Shot) Duracetal Brand (A1x1, A2x2, A3x1, A3.5x2, A4x1, B1x1,B2x2, B3x2, B4x1, C1x1, C3x2, C4x1, D2x1, D3x2, D4x1, G1x1, G2x1, G3x1, P1x2, P2x1, P3x1)
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBIResin, Denture, Relining, Repairing, Rebasing
EHPClasp, Preformed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2
EHPClasp, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842326103047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842326103047008423261030478423261030470842326103047

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, thermoplasticA thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight8Gram

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18004232683orders@myersontooth.com

Regulatory Flags#

DUNS number
857278431
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842326128095DuraflexDF-DPC-MD-6PK2026-05-26
00842326128101DuraflexDF-MPC-MD-6PK2026-05-26
00842326128118DuraflexDF-PNC-MD-6PK2026-05-26
00842326128125DuraflexDF-TTC-MD-6PK2026-05-26
00842326199620Trusana1TRUJR-U12025-10-24
00842326104693DuraflexDFDISC-NP-98-202025-09-04
00842326104709DuraflexDFDISC-NP-98-252025-09-04
00842326199460TrusanaTRU405-LTPNK-TRI2025-08-26
00842326199477TrusanaTRU405-DKPNK-TRI2025-08-26
00842326199484TrusanaTRU405-A1-N-TRI2025-08-26
00842326199491TrusanaTRU405-A2-N-TRI2025-08-26
00842326199507TrusanaTRU405-A3-N-TRI2025-08-26
00842326199514TrusanaTRU405-B1-N-TRI2025-08-26
00842326199521TrusanaTRU405-B2-N-TRI2025-08-26
00842326199538TrusanaTRU405-51-N-TRI2025-08-26
00842326104235VisiclearVCDISCB-98-152018-08-09
00842326104242VisiclearVCDISCB-98-202018-08-09
00842326199576Trusana1TRUJR-A12025-02-28
00842326199583Trusana1TRUJR-A22025-02-28
00842326199590Trusana1TRUJR-A32025-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07615208482775ProBase Hot / ProBase ColdIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-04-30
08056640078369major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-04-27
08056640078857major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-04-27
07701126631194Opti-Cryl Pour Acrylic Original X 22 lbPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AEBI2026-04-23
EPRC66100851dima Print Denture Base 2pro3dure medical GmbHEBI2025-07-31
08435288443584IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443591IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443614IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443645IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443669IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443690IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443607IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443621IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443638IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443652IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443676IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443683IDODENTINEUNION DENTAL SAEBI2024-11-27
EPOLPMMP10090Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10100Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10110Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10120Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10130Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10140Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10150Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10160Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10170Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10180Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10190Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10200Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10210Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17