FDA.report

A2 - Tips

Primary DI
D798A2TIP1
Brand
A2 - Tips
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
A2TIP
Catalog number
A2TIP
Device description
A2 Tips are 15 gauge, light impervious tips designed to dispense flowable, light cure adhesives. Qty 5 per packacge
Published
2016-07-18
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
true

Related Records

Product Codes

CodeName
KXRApplicator, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
KXRApplicator, ResinDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D798A2TIP1PrimaryHIBCC0
D798A2TIP0Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental material injection cannula, single-useA rigid or semi-rigid luminal device (dental tip) intended to channel and dispense a dental material/solution [e.g., restorative amalgam, resin, etching solution (etchant), topical dental anaesthetic] from a dental syringe, or similar applicator, to a patient’s teeth, oral mucosa, or gums; it is not intended to penetrate tissue (it is not a needle), not dedicated to root canal irrigation, and may be used for dental applications outside the patients mouth. This is a single-use device.

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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