FDA.reportPublic FDA data

Super Snap X-Treme Sample Pack

Primary DI
E235SSXTSAMPLE0
Brand
Super Snap X-Treme Sample Pack
Company
SHOFU DENTAL CORPORATION
Model
001
Catalog number
SSXT/SAMPLE
Device description
Contains DIs: E235L5070; E235L5220; E235L5310; E235L5320; E23504390
Published
2022-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EHLPoint, Abrasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHLPoint, AbrasiveDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E235SSXTSAMPLE0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive disk, reusableA dental instrument consisting of a circular flat or slightly conical sheet carrying or containing an abrasive, intended to perform a circular and/or oscillatory motion for polishing and finishing a cavity preparation and/or for cutting or polishing dental restorations. It is designed to be fixed at its centre to a mandrel and intended to be used with a dental power tool handpiece (e.g., straight or contra-angle). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(760) 736-3277customer-service@shofu.com

Regulatory Flags#

DUNS number
054618202
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E235DD16A1ML0DENTADISCDD16A1MLDD16A1ML2026-07-09
E235DD16A1MN0DENTADISCDD16A1MNDD16A1MN2026-07-09
E235DD16A2ML0DENTADISCDD16A2MLDD16A2ML2026-07-09
E235DD16A2MN0DENTADISCDD16A2MNDD16A2MN2026-07-09
E235DD16A35MN0DENTADISCDD16A35MNDD16A35MN2026-07-09
E235DD16A3MN0DENTADISCDD16A3MNDD16A3MN2026-07-09
E235DD16B1ML0DENTADISCDD16B1MLDD16B1ML2026-07-09
E235DD16B1MN0DENTADISCDD16B1MNDD16B1MN2026-07-09
E235DD16B2MN0DENTADISCDD16B2MNDD16B2MN2026-07-09
E235DD16B3MN0DENTADISCDD16B3MNDD16B3MN2026-07-09
E235DD16BL1MN0DENTADISCDD16BL1MNDD16BL1MN2026-07-09
E235DD16BL2MN0DENTADISCDD16BL2MNDD16BL2MN2026-07-09
E235DD16BL3ML0DENTADISCDD16BL3MLDD16BL3ML2026-07-09
E235DD16BL4MN0DENTADISCDD16BL4MNDD16BL4MN2026-07-09
E235DD16BLML0DENTADISCDD16BLMLDD16BLML2026-07-09
E235DD16BLMN0DENTADISCDD16BLMNDD16BLMN2026-07-09
E235DD16C1ML0DENTADISCDD16C1MLDD16C1ML2026-07-09
E235DD16C1MN0DENTADISCDD16C1MNDD16C1MN2026-07-09
E235DD16C2ML0DENTADISCDD16C2MLDD16C2ML2026-07-09
E235DD16C2MN0DENTADISCDD16C2MNDD16C2MN2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04548162350558GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350565GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350572GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350589GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350596GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350602GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350619GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350626GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350633GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350640GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350657GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350664GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
07897990301155PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990301209PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990301216PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399756PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399763PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399770PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399787PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399794PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399800PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399817PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399824PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399831PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399848PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399855PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399862PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399886PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399893PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399909PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18