FDA.report

All Ceramic Extra Oral Lithium Disilicate Wheels

Primary DI
D77941406017
Brand
All Ceramic Extra Oral Lithium Disilicate Wheels
Company
COSMEDENT, INC.
Model
414060
Published
2020-02-11
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
EHLPoint, Abrasive

Product Code Classifications

CodeDeviceSpecialtyClass
EHLPoint, AbrasiveDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D77941406017PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental abrasive disk, reusableA dental instrument consisting of a circular flat or slightly conical sheet carrying or containing an abrasive, intended to perform a circular and/or oscillatory motion for polishing and finishing a cavity preparation and/or for cutting or polishing dental restorations. It is designed to be fixed at its centre to a mandrel and intended to be used with a dental power tool handpiece (e.g., straight or contra-angle). This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
113911689
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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D7796722A11Bulkfill6722A12022-03-01
D7796722A21Bulkfill6722A22022-03-01
D7796722A31Bulkfill6722A32022-03-01
D7796722B11Bulkfill6722B12022-03-01
D779203101116 Gauge Black Tips2031012021-11-11
D7792031021018 Gauge Pink Tips2031022021-11-11
D7792031031119 Gauge Silver Tips2031032021-11-11
D7792031041222 Gauge Black Tips2031042021-11-11
D77920320212Mixing Tips CosmeCore 8gTips2032022021-11-11
D77920320413MirrorImage 10:1 Tips2032042021-11-11
D77920320515Adhere 1:1 Tips2032052021-11-11
D77920320615Connect 4:1 Tips2032062021-11-11
D77920330211CosmeCore IntraOral Tips2033022021-11-11
D77920340213White Plastic Nozzle Tips2034022021-11-11
D77920350315CosmeCore 50g Tip Package2035032021-11-11
D77970351T1Impressiv 5:1 Putty Cartridge Tips70531T2021-11-11

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