FDA.reportPublic FDA data

SUPER-SNAP IPR

Primary DI
E235SIPR40
Brand
SUPER-SNAP IPR
Company
SHOFU DENTAL CORPORATION
Model
SIPR4
Catalog number
SIPR4
Device description
SUPER-SNAP IPR GREEN SINGLE-SIDED (FINE) 10PK
Published
2026-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
E235SIPR40PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Interproximal reduction kitA collection of devices intended to be used for interproximal reduction (IPR), which is the reduction of contact between adjacent teeth during orthodontic alignment of the teeth. Fine abrasives are typically used to minimize pressure and allow the formation of spaces between the teeth, enabling more effective therapy without excessive interproximal contact, which may prolong or complicate teeth alignment. The device may include burs, abrasive disks, abrasive strips, thickness gauges and charts for tracking of reproximation. This device is reusable, but certain items will need to be replenished.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
054618202
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04548162300836ResiCem EXC0100C01002026-07-04
04548162300843ResiCem EXC0101C01012026-07-04
04548162300850ResiCem EXC0102C01022026-07-04
04548162300867ResiCem EXC0103C01032026-07-04
04548162344113ResiCem EXC0104C01042026-07-04
04548162350558GlossMaster ZRN0012N00122026-07-04
04548162350565GlossMaster ZRN0013N00132026-07-04
04548162350572GlossMaster ZRN0014N00142026-07-04
04548162350589GlossMaster ZRN0015N00152026-07-04
04548162350596GlossMaster ZRN0016N00162026-07-04
04548162350602GlossMaster ZRN0017N00172026-07-04
04548162350619GlossMaster ZRN0018N00182026-07-04
04548162350626GlossMaster ZRN0019N00192026-07-04
04548162350633GlossMaster ZRN0020N00202026-07-04
04548162350640GlossMaster ZRN0021N00212026-07-04
04548162350657GlossMaster ZRN0022N00222026-07-04
04548162350664GlossMaster ZRN0023N00232026-07-04
E235Y00030SHOFU RESIN GLAZEY0003Y00032026-06-08
E235Y00040SHOFU RESIN GLAZEY0004Y00042021-02-03
E235DPC0DentaprintDPCDPC2026-04-29

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