FDA.report

C&C

Primary DI
D798DCCCCK0
Brand
C&C
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
DCCCCK
Catalog number
DCCCCK
Device description
This kit is used for extrusion of teeth. This is a chemical cure self mix kit containing 3 Disposable Oval Attachments with Chain and 2 Disposable Pad Attachments with Chain, Excel Regular Self Mix syringe and Assure Bonding Resin.
Published
2016-07-25
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
false

Related Records

Product Codes

CodeName
ECOSpring, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
ECOSpring, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D798DCCCCK0PrimaryHIBCC0

GMDN Terms

TermDefinition
Dentine bonding agent/setA material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material. It includes a resin-based bonding agent and may also include a primer and/or etching solution (as a single formulation or as part of a set); composite resin is not included. It may also be used as an enamel bonding material. After application, this device cannot be reused.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature. Lowest 15c - Highest 30C

Sterilization Methods

Method

Contacts

PhoneEmail
630-773-4009paulgropi@aol.com

Regulatory Flags

DUNS number
113170088
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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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