FDA.reportPublic FDA data

UltraPrint-Dental Temp C&B UV

Primary DI
06971437940587
Brand
UltraPrint-Dental Temp C&B UV
Company
GUANGZHOU HEYGEARS IMC.INC
Model
2.0
Device description
UltraPrint-Dental Temp C&B UV, 160g/bottle, B2
Published
2022-10-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
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
K213643000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213643000UltraPrint-Dental Temp C&B UVGuangzhou Heygears IMC., Inc.2022-01-14EBG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971437940587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971437940587069714379405876971437940587

GMDN Terms#

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

Regulatory Flags#

DUNS number
418561545
Device count
1
DM exempt
false
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
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
06971437943618UltraPrint Flexible Denture UV1.02026-08-27
06971437943625UltraPrint Flexible Denture UV1.02026-08-27
06971437943649UltraPrint Flexible Denture UV1.02026-08-27
06971437943700UltraPrint Flexible Denture UV1.02026-08-27
06971437943748UltraPrint Flexible Denture UV1.02026-08-27
06971437942314UltraPrint Denture UV2.02026-03-05
06971437942321UltraPrint Denture UV2.02026-03-05
06971437942338UltraPrint Denture UV2.02026-03-05
06971437942352UltraPrint Denture UV2.02026-03-05
06971437942376UltraPrint Denture UV2.02026-03-05
06971437942383UltraPrint Denture UV2.02026-03-05
06971437942390UltraPrint Denture UV2.02026-03-05
06971437942406UltraPrint Denture UV2.02026-03-05
06971437942413UltraPrint Denture UV2.02026-03-05
06971437941249UltraPrint-Dental Surgical Guide UV1.02022-12-07
06971437941256UltraPrint-Dental Surgical Guide UV1.02022-12-07
06971437941263UltraPrint-Dental Surgical Guide UV1.02022-12-07
06971437940457UltraPrint-Dental Denture Teeth UV1.02022-10-24
06971437940464UltraPrint-Dental Denture Teeth UV1.02022-10-24
06971437940471UltraPrint-Dental Denture Teeth UV1.02022-10-24

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Primary DI, Brand, Company table
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