FDA.report

BandLok

Primary DI
D798BLSA0
Brand
BandLok
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
BLSA
Catalog number
BLSA
Device description
BandLok is intended for use as a chemical cure band cement. This is the 6 gm syringe of Part A, natural shade.
Published
2016-09-03
Public version status
Update
Distribution status
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
EBFMaterial, Tooth Shade, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D798BLSA0PrimaryHIBCC0

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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store refrigerated (2-8 Degrees C)

Sterilization Methods

Method

Contacts

PhoneEmail
6307734009paulgropi@aol.com

Regulatory Flags

DUNS number
113170088
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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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00840479203300RELIAMOLDSRMKB2026-03-12
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00840479203379BOND A BRAID 6 INCH LINGUAL RETAINER WIRESSAMBAB22026-03-12
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