FDA.reportPublic FDA data

DENTCA Crown and Bridge for Carbon Printers

Primary DI
00856551007049
Brand
DENTCA Crown and Bridge for Carbon Printers
Company
DENTCA, INC.
Model
DENTCA Crown and Bridge for Carbon Printers
Device description
DENTCA Crown and Bridge for Carbon Printers - A2 - 1kg
Published
2021-10-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192806000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192806000DENTCA Crown and BridgeDentca, Inc.2020-02-05EBG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856551007049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856551007049008565510070498565510070490856551007049

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight1Kilogram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place. Do not expose to direct sunlight.
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(424)558-8726info@dentca.com

Regulatory Flags#

DUNS number
022455143
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856551007520DENTCA Base PremiumDENTCA Base Premium2023-04-03
00856551007537DENTCA Base PremiumDENTCA Base Premium2023-04-03
00856551007544DENTCA Base PremiumDENTCA Base Premium2023-04-03
00856551007551DENTCA Base PremiumDENTCA Base Premium2023-04-03
00856551007568DENTCA Base Hi-ImpactDENTCA Base Hi-Impact2023-04-03
00856551007575DENTCA Base Hi-ImpactDENTCA Base Hi-Impact2023-04-03
00856551007582DENTCA Base Hi-ImpactDENTCA Base Hi-Impact2023-04-03
00856551007599DENTCA Base Hi-ImpactDENTCA Base Hi-Impact2023-04-03
00856551007605Formlabs Denture Base resinFormlabs Denture Base resin2021-10-29
00856551007612Formlabs Denture Base resinFormlabs Denture Base resin2021-10-29
00856551007629Formlabs Denture Base resinFormlabs Denture Base resin2021-10-29
00856551007636Formlabs Denture Base resinFormlabs Denture Base resin2021-10-29
00856551007704Formlabs Denture Teeth resinFormlabs Denture Teeth resin2021-10-29
00856551007711Formlabs Denture Teeth resinFormlabs Denture Teeth resin2021-10-29
00856551007728Formlabs Denture Teeth resinFormlabs Denture Teeth resin2021-10-29
00856551007735Formlabs Denture Teeth resinFormlabs Denture Teeth resin2021-10-29
00856551007742Formlabs Denture Teeth resinFormlabs Denture Teeth resin2021-10-29
00856551007759Formlabs Denture Teeth resinFormlabs Denture Teeth resin2021-10-29
00856551007766Formlabs Denture Teeth resinFormlabs Denture Teeth resin2021-10-29
00856551007001DENTCA Try-inDENTCA Denture Base II2019-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EPOLPMFLAG5600PMMA CAD/CAM discPOLIDENT d.o.o.EBG2025-05-13
EPOLPMMA1270PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA1350PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA1430PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA0230PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0310PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0390PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0470PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0550PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0630PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0710PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0790PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0870PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0950PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0070PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1030PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1110PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1190PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLKML200160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML200200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML201160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML201200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML202160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML202200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML203160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML203200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML204160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML204200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML205160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML205200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02