FDA.report

Yates Motloid Coldpac Tooth Acrylic

Primary DI
00706069312947
Brand
Yates Motloid Coldpac Tooth Acrylic
Company
BIRD-X, INC.
Model
TP04VB4
Device description
Coldpac Tooth Acrylic, Temporary Crown and Bridge Resin. Shade #B4 4oz.
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

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
00706069312947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00706069312947007060693129477060693129470706069312947

GMDN Terms

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

TypeValueUnit
Weight0.25Pound

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit72 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

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

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00706069323110YATES MOTLOID SET-RITE WAX470012023-06-26
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00706069323257YATES MOTLOID ALL SEASON WAX470152023-06-26
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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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