FDA.report

C&C

Primary DI
D798DCCK0
Brand
C&C
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
DCCK
Catalog number
DCCK
Device description
The C&C system is intended for use by a dental professional for extrusion of an impacted tooth. Kit contains 3 Disposable Oval Attachments with Chain and 2 Disposable Pad Attachments with Chain, Flowtain adhesive and Assure Universal 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
D798DCCK0PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthodontic bracket adhesiveA bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Special Storage Condition, Specify: TEMPERATURE LIMITATION: Store at room temperature (15-30 Degrees C)

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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