FDA.report

Crown-Lok

Primary DI
D798CLSB0
Brand
Crown-Lok
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
CLSB
Catalog number
CLSB
Device description
Crown Lok™ is intended for use as a cement for metal crowns and orthodontic bands. This is a 6gm Screw Paste B Syringe
Published
2016-09-03
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
false

Related Records

Product Codes

CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D798CLSB0PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental prosthesis veneer resinA dental resin composite material intended to be used for veneering a restorative dental prosthesis (e.g., crown, bridge, fixed or removable denture); some types may be used as stains to apply colour to the dental appliance. After application, this material cannot be reused.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00TEMPERATURE LIMITATION: Store at room temperature (15-30 C )

Sterilization Methods

Method

Contacts

PhoneEmail
6307734009paulgropi@aol.com

Regulatory Flags

DUNS number
113170088
Device count
1
DM exempt
false
Premarket exempt
false
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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