FDA.report

A2

Primary DI
D798AO1
Brand
A2
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
AO
Catalog number
AO
Device description
A2 Oval Attachment Form can be used for the retention of themoplastic aligners and for horizontal or vertical placement on the tooth depending on the height of the crown.
Published
2016-07-25
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
KXRApplicator, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
KXRApplicator, ResinDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D798AO1PrimaryHIBCC0
D798AO0Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental mouldA hollow form in which a dental material is intended to be injected, cast, or pressed to produce a particular shape.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at ambient conditions.

Sterilization Methods

Method

Contacts

PhoneEmail
6307734009paulgropi@aol.com

Regulatory Flags

DUNS number
113170088
Device count
5
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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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