FDA.report

BAND-RITE™, Ortho-Choice™

Primary DI
D701OCBR2
Brand
BAND-RITE™, Ortho-Choice™
Company
PULPDENT CORPORATION
Model
OCBR
Device description
2-PASTE RESIN-IONOMER ORTHO BAND CEMENT, DUAL CURE, FLUORIDE RELEASING KIT: 22.8 gm base, 25.2 gm catalyst, mixing pad, spatulas
Published
2016-07-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DYHAdhesive, Bracket And Tooth Conditioner, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
DYHAdhesive, Bracket And Tooth Conditioner, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D701OCBR2PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthodontic bracket adhesiveA bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.

Sterilization Methods

Method

Regulatory Flags

DUNS number
001006089
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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D701VBF2US2ACTIVA™ BioACTIVE Bulk FlowVBF2US2025-05-12
D701VKBFS2ACTIVA™ Kids BioACTIVE Bulk FlowVKBFS2025-05-12
D701T20G191Applicator TipsT20G192024-12-03
D701SVBFUS2ACTIVA™ BioACTIVE Bulk FlowS-VBFUS2024-12-02
D701SVKBFUS2ACTIVA™ Kids BioACTIVE Bulk FlowS-VKBFUS2024-12-02
D701VBF1US2ACTIVA™ BioACTIVE Bulk FlowVBF1US2024-12-02
D701VKBF1OW2ACTIVA™ Kids BioACTIVE Bulk FlowVKBF1OW2024-12-02
D710VKBF1US2ACTIVA™ Kids BioACTIVE Bulk FlowVKBF1US2024-12-02
D701SUNO2DENTASTIC UNO SAMPLESUNO2018-08-10
D701SVPFA32Activa PrestoS-VPFA32023-06-22
D701SVPFA352Activa PrestoS-VPFA352023-06-22
D701SVPFA42Activa PrestoS-VPFA42023-06-22
D701SVPFA62Activa PrestoS-VPFA62023-06-22
D701SVPFB12Activa PrestoS-VPFB12023-06-22
D701TTP502Tuff Temp Plus Provisional Veneer, Crown, and Bridge ResinTTP502018-12-14
D701TTP50A12TUFF-TEMP PLUSTTP50A12019-11-22
D701TTP50A1X2TUFF-TEMP PLUSTTP50A1X2019-11-22
D701TTP50A22TUFF-TEMP PLUSTTP50A22019-11-22
D701TTP50A2X2TUFF-TEMP PLUSTTP50A2X2019-11-22
D701TTP50A32TUFF-TEMP PLUSTTP50A32019-11-22

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840479203652EXCEL REGULARRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-13
07290115050035High-Q-Bond Bracket AdhesiveB.J.M. LABORATORIES LTDDYH2026-03-13
07290115051896Ideal 1 Orthodontic Bracket AdhesiveB.J.M. LABORATORIES LTDDYH2026-03-13
07290115051902High-Q-Bond BandB.J.M. LABORATORIES LTDDYH2026-03-13
00840479203317RELY A BONDRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-12
00840479202372PHASE IIRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202389PHASE IIRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202396PHASE IIRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202402PHASE IIRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202419PHASE IIRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202426PHASE IIRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202433PLASTIC CONDITIONERRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202440PADLOCK PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202457PADLOCK PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202464PADLOCK PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202570PHASE IIRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479201894LIGHT BOND REGULAR PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479201900LIGHT BOND REGULAR PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479201924LIGHT BOND THIN PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479201931LIGHT BOND FILLED SEALANTRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479201948LIGHT BOND FILLED SEALANTRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479201979LIGHT BOND REGULAR SEALANTRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479201986LIGHT BOND MEDIUM PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479201993LIGHT BOND REGULAR PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479202006LIGHT BOND REGULAR PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479202082MAXIMUM CURERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479202099MAXIMUM CURERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479202105MAXIMUM CURERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479202136METAL PRIMERRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479202259PADLOCK PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10