FDA.report

Stick and Place

Primary DI
D798SNP161
Brand
Stick and Place
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
SNP16
Catalog number
SNP16
Device description
Stick and Place veneer placing instruments
Published
2016-11-15
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
D798SNP161PrimaryHIBCC0
D798SNP0Unit of UseHIBCC0

GMDN Terms

TermDefinition
Orthodontic aligner auxiliary attachment kitA collection of devices, used with retainer-style orthodontic appliances (e.g., preformed teeth aligners) to further facilitate and enhance teeth alignment. The kit includes buttons and elastics, typically made of clear materials for aesthetic purposes, that are attached to the orthodontic aligner and/or teeth to help achieve extrusion, rotation and anchorage control. This provides the clinician with greater control to achieve additional tooth movement during the treatment. The contents of this kit may also include plastic/composite adhesive, etchant, elastics, burs and polishing wheels for cutting the aligners. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at ambient conditions.

Sterilization Methods

Method

Contacts

PhoneEmail
630-773-4009paulgropi@aol.com

Regulatory Flags

DUNS number
113170088
Device count
16
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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