FDA.reportPublic FDA data

Trusana

Primary DI
00842326199538
Brand
Trusana
Company
The Myerson Company Limited
Model
TRU405-51-N-TRI
Device description
500ml 3D Printing Resin 405nm Shade 51 for teeth
Published
2025-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
PZYAdditively Manufactured, Preformed, Resin Denture Tooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZYAdditively Manufactured, Preformed, Resin Denture ToothDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842326199538PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842326199538008423261995388423261995380842326199538

GMDN Terms#

Term, Definition table
TermDefinition
Resin artificial teethPrefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18004232683orders@myersontooth.com

Regulatory Flags#

DUNS number
857278431
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
00842326199576Trusana1TRUJR-A12025-02-28
00842326199583Trusana1TRUJR-A22025-02-28
00842326199590Trusana1TRUJR-A32025-02-28
00842326199606Trusana1TRUJR-B12025-02-28
00842326199637Trusana1TRUJR-OGPNK2025-02-28
00842326199651Trusana1TRUJR-LRPNK2025-02-28
00842326199668Trusana1TRUJR-DKPNK2025-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18056865154463ACRY NATURE AFG 6 UPPERDENTAL MANUFACTURING SPAPZY2026-03-17
18056865155644ACRY NATURE AFG 6 LOWERDENTAL MANUFACTURING SPAPZY2026-03-17
28056865155658ACRY NATURE AFG 8 UPPERDENTAL MANUFACTURING SPAPZY2026-03-17
28056865155665ACRY NATURE AFG 8 LOWERDENTAL MANUFACTURING SPAPZY2026-03-17
E241VT0120Cavex Instant StoneCavex Holland B.V.PZY2026-03-10
06971437944776UltraPrint Denture Teeth UVGUANGZHOU HEYGEARS IMC.INCPZY2026-01-14
06971437944783UltraPrint Denture Teeth UVGUANGZHOU HEYGEARS IMC.INCPZY2026-01-14
06971437944790UltraPrint Denture Teeth UVGUANGZHOU HEYGEARS IMC.INCPZY2026-01-14
06971437944806UltraPrint Denture Teeth UVGUANGZHOU HEYGEARS IMC.INCPZY2026-01-14
06971437944813UltraPrint Denture Teeth UVGUANGZHOU HEYGEARS IMC.INCPZY2026-01-14
06971437944820UltraPrint Denture Teeth UVGUANGZHOU HEYGEARS IMC.INCPZY2026-01-14
06971437944837UltraPrint Denture Teeth UVGUANGZHOU HEYGEARS IMC.INCPZY2026-01-14
06971437944844UltraPrint Denture Teeth UVGUANGZHOU HEYGEARS IMC.INCPZY2026-01-14
06971437944851UltraPrint Denture Teeth UVGUANGZHOU HEYGEARS IMC.INCPZY2026-01-14
06971437944868UltraPrint Denture Teeth UVGUANGZHOU HEYGEARS IMC.INCPZY2026-01-14
07898561547736PriZma 3D Bio Crown - BL (250 g)Maquira Industria de Produtos Odontologicos S/APZY2025-09-05
07898561547743PriZma 3D Bio Crown - BL (500 g)Maquira Industria de Produtos Odontologicos S/APZY2025-09-05
07898561547767PriZma 3D Bio Crown - A1 (250 g)Maquira Industria de Produtos Odontologicos S/APZY2025-09-05
07898561547774PriZma 3D Bio Crown - A1 (500 g)Maquira Industria de Produtos Odontologicos S/APZY2025-09-05
07898561547798PriZma 3D Bio Crown - A2 (250 g)Maquira Industria de Produtos Odontologicos S/APZY2025-09-05
07898561547804PriZma 3D Bio Crown - A2 (500 g)Maquira Industria de Produtos Odontologicos S/APZY2025-09-05
07898561548238PriZma 3D Bio Crown - A3 (250 g)Maquira Industria de Produtos Odontologicos S/APZY2025-09-05
00842326199484TrusanaThe Myerson Company LimitedPZY2025-08-26
00842326199491TrusanaThe Myerson Company LimitedPZY2025-08-26
00842326199507TrusanaThe Myerson Company LimitedPZY2025-08-26
00842326199514TrusanaThe Myerson Company LimitedPZY2025-08-26
00842326199521TrusanaThe Myerson Company LimitedPZY2025-08-26
D0019064150LucitoneDentsply International Inc.PZY2025-07-01
D0019064170LucitoneDentsply International Inc.PZY2025-07-01
00842326199576Trusana1The Myerson Company LimitedPZY2025-02-28