FDA.report

The Ultimate F & P Kit

Primary DI
D6585550101
Brand
The Ultimate F & P Kit
Company
Gc America Inc.
Model
555010
Catalog number
555010
Device description
The Ultimate F & P Kit refill pack, point shape polisher, 6 pack
Published
2017-02-10
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
EJQWHEEL, POLISHING AGENT

Product Code Classifications

CodeDeviceSpecialtyClass
EJQWheel, Polishing AgentDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D6585550101PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental mandrelA slender, round, metal shaft designed to be used chairside to hold (locked into place) a rotating dental device, e.g., a grinding wheel, abrasive disk, circular saw, or a disk, stone or cup used for grinding or polishing. The mandrel will be placed into a dental handpiece that will rotate at high speed. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(708)597-0900customerservice@gcamerica.com

Regulatory Flags

DUNS number
005473608
Device count
1
DM exempt
false
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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D6581211012COE ALGINATE™1211011211012016-08-01
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D6581241012COE HYDROPHILIC GEL™1241011241012016-08-01
D6581241251COE HYDROPHILIC GEL™1241251241252016-08-01
D6581310022COE-FLEX®1310021310022016-08-01
D6581310032COE-FLEX®1310031310032016-08-01
D6581310042COE-FLEX®1310041310042016-08-01
D6581310052COE-FLEX®1310051310052016-08-01
D6581311022COE-FLEX®1311021311022016-08-01
D6581311032COE-FLEX®1311031311032016-08-01
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