FDA.reportPublic FDA data

Yates Motloid Coldpac Tooth Acrylic

Primary DI
00706069313661
Brand
Yates Motloid Coldpac Tooth Acrylic
Company
BIRD-X, INC.
Model
TP16TW
Device description
Coldpac Tooth Acrylic, Temporary Crown and Bridge Resin. Shade #Tooth White, 16oz.
Published
2016-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00706069313661PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00706069313661007060693136617060693136610706069313661

GMDN Terms#

Term, Definition table
TermDefinition
Dental crown/bridge, temporaryA prosthetic dental device used to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight1Pound

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit72 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
312-226-2473GUDID@yates-motloid.com

Regulatory Flags#

DUNS number
025055773
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
true
Expiration date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00706069323110YATES MOTLOID SET-RITE WAX470012023-06-26
00706069323158YATES MOTLOID SET-RITE WAX470052023-06-26
00706069323257YATES MOTLOID ALL SEASON WAX470152023-06-26
00706069323356YATES MOTLOID RED REFINED WAX473152023-06-26
00706069323448YATES MOTLOID RIJFORM BITE RIMS474152023-06-26
00706069343163Yates Motloid Coldpac Denture and Repair AcrylicDK16012016-08-26
00706069343361Yates Motloid Coldpac Denture and Repair AcrylicDK16032016-08-26
00706069343538Yates Motloid Coldpac Denture and Repair AcrylicDK32052016-08-26
00706069343569Yates Motloid Coldpac Denture and Repair AcrylicDK16052016-08-26
00706069343767Yates Motloid Coldpac Denture and Repair AcrylicDK16072016-08-26
00706069343835Yates Motloid Coldpac Denture and Repair AcrylicDK32082016-08-26
00706069343866Yates Motloid Coldpac Denture and Repair AcrylicDK16082016-08-26
00706069353131Yates Motloid Coldpac Denture and Repair AcrylicDP32012016-08-26
00706069353162Yates Motloid Coldpac Denture and Repair AcrylicDP16012016-08-26
00706069353193Yates Motloid Coldpac Denture and Repair AcrylicDP96012016-08-26
00706069353339Yates Motloid Coldpac Denture and Repair AcrylicDP32032016-08-26
00706069353360Yates Motloid Coldpac Denture and Repair AcrylicDP16032016-08-26
00706069353537Yates Motloid Coldpac Denture and Repair AcrylicDP32052016-08-26
00706069353568Yates Motloid Coldpac Denture and Repair AcrylicDP16052016-08-26
00706069353599Yates Motloid Coldpac Denture and Repair AcrylicDP96052016-08-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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