FDA.report

MIRACAST MODEL FORMER (LOWER)

Primary DI
D2482030671
Brand
MIRACAST MODEL FORMER (LOWER)
Company
HAGER WORLDWIDE, INC.
Model
203067
Device description
MIRACAST MODEL FORMER (LOWER)
Published
2023-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EBHMATERIAL, IMPRESSION TRAY, RESIN

Product Code Classifications

CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D2482030671PrimaryHIBCC0
D2482030670Unit of UseHIBCC0

GMDN Terms

TermDefinition
Custom-made dental anatomy modelA dental device made of gypsum (e.g., plaster, dental stone) intended to be used as a replica (model) of a specific patient’s teeth and gums, to assist with a dental treatment-related procedure (e.g., production of a dental restoration, design of a teeth whitening tray). It is created via casting (i.e., taking the impression of the patient’s teeth/gums, pouring plaster into the impression, and then removing the impression). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(828)624-3319d.pritchard@hagerworldwide.com

Regulatory Flags

DUNS number
009277971
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
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D248938520Uni-Wedge Regular ( Orange)938522026-01-28
D2486300620TS1 Tongue Vacuum Cleaner6300622024-08-20
D2483552470The Prepster (also known as LaminateButler)3552472024-07-15
D2483552520BurButler ( 5 Hole Orange Base w/Lid)3552522024-07-15
D2483552530BurButler ( 10 Hole White Base w/Lid)3552532024-07-15
D2483552540BurButler ( 10 Hole Pink Base w/Lid)3552542024-07-15
D2483552560BurButler ( 10 Hole Blue Base w/Lid)3552562024-07-15
D2483552600BurButler ( 25 Hole Pink Base w/Lid)3552602024-07-15
D2483552620BurButler ( 25 Hole Blue Base w/Lid)3552622024-07-15
D2486054510Mirahold Child6054512024-07-03
D248137720Almore Aluminum Oxide137722024-05-20
D248137730Almore Aluminum Oxide137732024-05-20
D248B1619B0DurationB16212024-05-20
D248B16280Uni-TipB1629C2024-05-20
D2481550180Reso-Pac Hydrophilic Periodontal Dressing1550182016-09-22
D2481550190Reso-Pac Hydrophilic Periodontal Dressing1550192016-09-22
D2483553190Plast Frame3553192024-04-16
D248222300SafeDispense - Silver222302024-04-12
D248222310Mini SafeDispense222312024-04-12
D248222360SafeDispense - White222362024-04-12

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
00850061175151H-0600 ResinFORMLABS OHIO INC.EBH2025-12-01
EDET047221RS VIVO IBT 1000gDETAX GmbHEBH2025-11-20
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
06975471800067PionextShenzhen Piocreat 3D Technology Co., LtdEBH2024-12-26
06975471800074PionextShenzhen Piocreat 3D Technology Co., LtdEBH2024-12-26
06975471800081PionextShenzhen Piocreat 3D Technology Co., LtdEBH2024-12-26
06975471800098PionextShenzhen Piocreat 3D Technology Co., LtdEBH2024-12-26
06975471800104PionextShenzhen Piocreat 3D Technology Co., LtdEBH2024-12-26
06975471800111PionextShenzhen Piocreat 3D Technology Co., LtdEBH2024-12-26