FDA.report

TEMP TABS NATURAL

Primary DI
D8161430330
Brand
TEMP TABS NATURAL
Company
ALL DENTAL PRODX
Model
143033
Device description
A thermoplastic material designed to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. It is composed of a mixture of natural resins, fillers, and lubricants. This is a single-use device.
Published
2016-09-20
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

Contact Domains

Product Codes

CodeName
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D8161430330PrimaryHIBCC0

GMDN Terms

TermDefinition
Composite dental impression materialA thermoplastic material designed to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. It is composed of a mixture of natural resins, fillers, and lubricants. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit78 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
877-647-7639kateliddle@alldentalprodx.com

Regulatory Flags

DUNS number
002287223
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D816200130GB0QuikGlaze200130GB2016-09-20
D8161430200TEMP TABS TRUE BLUE1430202016-09-20
D8161447001Bite Buddy1447002016-09-20

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