FDA.reportPublic FDA data

SureSmile

Primary DI
D001V181001
Brand
SureSmile
Company
Dentsply International Inc.
Model
V18100
Published
2022-11-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OYHOrthodontic vibratory accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OYHOrthodontic Vibratory AccessoryDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D001V181001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic vibratorAn electronic device designed to be used in the home during treatment with orthodontic appliances (e.g., brackets, aligners) to provide small vibrations for gently accelerating the movement of anterior teeth, guided by the appliances, to help reduce treatment time and pain. It is in the form of a biteable plastic mouthpiece attached to a hands-free vibratory unit. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
795572718
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D0026243451Enhance® mini Finishing System6243456243452022-04-11
D0026243551Enhance® mini Finishing System6243556243552022-04-11
D0026243651Enhance® mini Finishing System6243656243652022-04-11
D0026243751Enhance® mini Finishing System6243756243752022-10-13
D0026243851Enhance® mini Finishing System6243856243852022-04-11
D002624550001Polytrays62455000624550002022-07-07
D002624550011Polytrays62455001624550012022-07-07
D002624550021Polytrays62455002624550022022-07-07
D002624551001Polytrays62455100624551002022-07-07
D002624551011Polytrays62455101624551012022-07-07
D002624551021Polytrays62455102624551022022-07-07
D002624551031Polytrays62455103624551032022-07-07
D002624551051Polytrays62455105624551052022-07-07
D0026076071Calibra® Bio Bioceramic Luting Cement6076076076072022-04-20
D0026590301Palodent® Sectional Matrix System6590306590302019-04-02
D0026590701Palodent® Sectional Matrix System6590706590702019-04-02
D0026631001AutoMate®6631006631002019-04-02
D0013010121Ceramco® 3Powder Opaque i2/i43010122016-09-21
D0013010211Ceramco® 3Powder Opaque D23010212016-09-21
D0013010311Ceramco® 3Powder Opaque Modifier Yellow3010312016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D001V181021SureSmileDentsply International Inc.OYH2022-11-11
D001V181151ByteDentsply International Inc.OYH2022-11-11
00852673007240Acceledent OptimaPROPEL ORTHODONTICS LLCOYH2020-07-31
00852673007103VProPROPEL ORTHODONTICS LLCOYH2020-03-23
00852673007189VPro+PROPEL ORTHODONTICS LLCOYH2020-03-17
00852673007127HyperBytePROPEL ORTHODONTICS LLCOYH2020-01-14
00852673007073PropelPROPEL ORTHODONTICS LLCOYH2018-03-06
00865515000217AcceleDent ORTHOACCEL TECHNOLOGIES, INC.OYH2017-06-16
00865515000200AcceleDentORTHOACCEL TECHNOLOGIES, INC.OYH2016-09-06