FDA.report

OpaTray

Primary DI
D815OPATRAY1
Brand
OpaTray
Company
OPA DENTAL LLC
Model
OPATRAY
Catalog number
OPATRAY
Device description
Light cure custom tray 2pcs
Published
2018-10-21
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
EBHMaterial, Impression Tray, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D815OPATRAY1PrimaryHIBCC0
D815OPATRAY01Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental impression tray materialA material intended to be used to create a custom impression tray intended for filling with dental impression materials; it is not intended for the fabrication of a patient-worn dental appliance. The tray is typically made by applying the material to a preliminary plaster or stone model of the patient's teeth and gums. The material is used in cases in which a preformed impression tray is not suitable. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
053308044
Device count
2
DM exempt
false
Premarket exempt
true
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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D815OPAFLOW2DR0OPAOPAFLOW2DROPAFLOW2DR2023-12-14
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D815OPAFIT3HCLG0OpaFitOPAFIT3HCLGOPAFIT3HCLG2021-08-16
D815PKDZLZ0Zubler USAPKDZLZPKDZLZ2020-06-04
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