UltraPrint-Dental Temp C&B UV

Primary DI
00850026127010
Brand
UltraPrint-Dental Temp C&B UV
Company
Heygears Inc.
Model
1.0
Device description
500g, UltraPrint-Dental Temp C&B UV-A1
Published
2021-01-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200273000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200273000FREEPRINT tempDetax GmbH & Co. KG2020-10-27EBG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850026127010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850026127010008500261270108500261270100850026127010

GMDN Terms#

Term, Definition table
TermDefinition
Dental crown/bridge resin, temporaryA material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
111627614
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850026127072UltraPrint-Dental Denture UV1.02021-01-21
00850026127003UltraPrint-Dental Temp C&B UV1.02021-01-12
00850026127027UltraPrint-Dental Temp C&B UV1.02021-01-12
00850026127034UltraPrint-Dental Temp C&B UV1.02021-01-12
00850026127041UltraPrint-Dental Temp C&B UV1.02021-01-12
00850026127058UltraPrint-Dental Temp C&B UV1.02021-01-12

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