FDA.reportPublic FDA data

Power Dental USA

Primary DI
D9437303UL00
Brand
Power Dental USA
Company
Power Dental U.S.A. Inc.
Model
7303UL
Catalog number
7303UL
Device description
IMPRESSION TRAYS SOLID, DENTURE, UPPER, L
Published
2021-07-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBHMATERIAL, IMPRESSION TRAY, RESIN
EISREMOVER, CROWN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1
EISRemover, CrownDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D9437303UL00PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression tray, reusableA horseshoe-shaped receptacle made of metal or plastic designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression. The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(815)363-8003info@mydentalusa.com

Regulatory Flags#

DUNS number
081305064
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D943ORCAA0Power Dental USAORCAAORCAA2021-06-20
D94367350Power Dental USA673567352021-06-20
D94367380Power Dental USA673867382021-06-20
D94367390Power Dental USA673967392021-06-20
D94367410Power Dental USA674167412021-06-20
D94367430Power Dental USA674367432021-06-20
D9431007E0Power Dental USA1007E1007E2021-07-13
D94315240Power Dental USA152415242021-06-20
D94335090Power Dental USA350935092021-06-20
D9434826XAS0Power Dental USA4826XAS4826XAS2021-07-13
D94362100Power Dental USA621062102021-06-20
D94364470Power Dental USA644764472022-01-08
D943813050Power Dental USA8130-58130-52021-07-13
D943DCAM0Power Dental USADCAMDCAM2021-07-13
D943DCAM30Power Dental USADCAM3DCAM32021-07-13
D943KIM10Power Dental USAKIM-1KIM-12022-07-12
D943KIM120Power Dental USAKIM-12KIM-122022-07-12
D943KIM20Power Dental USAKIM-2KIM-22022-07-12
D943KIM240Power Dental USAKIM-24KIM-242021-07-13
D943KIM30Power Dental USAKIM-3KIM-32022-07-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G14934001F08TBS DentalACME ENTERPRISE.EIS2026-03-02
08906139320670Taglus Model ResinLAXMI DENTAL LIMITEDEBH2026-01-09
08906139320694Taglus Model Resin SLAXMI DENTAL LIMITEDEBH2026-01-09
08906139323473Taglus Model Resin OdourlessLAXMI DENTAL LIMITEDEBH2026-01-09
06975338701292SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBH2025-12-09
06975338701308SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBH2025-12-09
04963931210794NAYDM CORPORATIONEIS2025-12-05
04963931210800NAYDM CORPORATIONEIS2025-12-05
00850061175151H-0600 ResinFORMLABS OHIO INC.EBH2025-12-01
EDET047221RS VIVO IBT 1000gDETAX GmbHEBH2025-11-20
00841336106086Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2025-11-11
00841336108646Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2025-11-11
00841336108660Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2025-11-11
E235S3DMR0DentaprintSHOFU DENTAL CORPORATIONEBH2025-08-26
E235S3DOR0DentaprintSHOFU DENTAL CORPORATIONEBH2025-08-26
07701126901075Portux 3D Printing Resin Basic Gray x 500gPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AEBH2025-08-11
07701126901204Portux 3D Printing Resin Dental ModelsPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AEBH2025-08-11
07701126901235Portux 3D Printing Resin Model 2.0PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AEBH2025-08-11
04260635981587RS VIVO TrayDeltaMed GmbHEBH2025-07-29
EDEL162162003Delta Tray RoseDeltaMed GmbHEBH2025-07-29
D7091084045M-PRINT TryInMerz Dental GmbHEBH2025-07-08
D7091084046M-PRINT TryInMerz Dental GmbHEBH2025-07-08
D7091084047M-PRINT TryInMerz Dental GmbHEBH2025-07-08
D7091084048M-PRINT TryInMerz Dental GmbHEBH2025-07-08
16978499313042RAYFORM TechnologyZiyang Rayform Technology Co., Ltd.EBH2025-05-09
EPRC768507UCAN Print Traypro3dure medical GmbHEBH2025-03-31
E239D4210ZS1DrufoplastDreve Dentamid GmbHEBH2025-03-21
06975471800036PionextShenzhen Piocreat 3D Technology Co., LtdEBH2024-12-26
06975471800043PionextShenzhen Piocreat 3D Technology Co., LtdEBH2024-12-26
06975471800050PionextShenzhen Piocreat 3D Technology Co., LtdEBH2024-12-26