FDA.report

OpaBite

Primary DI
D815OPABITE1
Brand
OpaBite
Company
OPA DENTAL LLC
Model
OPABITE
Catalog number
OPABITE
Device description
Bite registration 50ml cartridge
Published
2018-10-19
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
true

Related Records

Product Codes

CodeName
ELWMaterial, Impression

Product Code Classifications

CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D815OPABITE1PrimaryHIBCC0
D815OPABITE01Unit of UseHIBCC0

GMDN Terms

TermDefinition
Silicone dental impression materialAn elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
053308044
Device count
2
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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D815VCR9820DARK0VEICRRVCR9820DARKVCR9820DARK2024-06-10
D815VCR9820LIGHT0VEICRRVCR9820LIGHTVCR9820LIGHT2024-06-10
D815OPAFILL4DO0OPAOPAFILL4DOOPAFILL4DO2023-12-14
D815OPAFILL4DR0OPAOPAFILL4DROPAFILL4DR2023-12-14
D815OPAFILL4P20OPAOPAFILL4P2OPAFILL4P22023-12-14
D815OPAFLOW2DO0OPAOPAFLOW2DOOPAFLOW2DO2023-12-14
D815OPAFLOW2DR0OPAOPAFLOW2DROPAFLOW2DR2023-12-14
D815OPAFLOW2LR0OPAOPAFLOW2LROPAFLOW2LR2023-12-14
D815OPAFLOW2LT0OPAOPAFLOW2LTOPAFLOW2LT2023-12-14
D815OPAFLOW2P10OPAOPAFLOW2P1OPAFLOW2P12023-12-14
D815OPAFLOW2P20OPAOPAFLOW2P2OPAFLOW2P22023-12-14
D815OPAFLOW2W0OPAOPAFLOW2WOPAFLOW2W2023-12-14
PMMA9825CLEAR0LunaPMMA9825CLEARPMMA9825CLEAR2017-04-18
D815MIXERHBLG01Opa Mixer/tipMIXERHBLG1MIXERHBLG12021-08-17
D815OPACEM8TR0OpaCemOPACEM8TROPACEM8TR2021-08-17
D815OPAFIT3HCLG0OpaFitOPAFIT3HCLGOPAFIT3HCLG2021-08-16
D815PKDZLZ0Zubler USAPKDZLZPKDZLZ2020-06-04
PMMA9520A00LunaPMMA9520A0PMMA9520A02017-04-18

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