FDA.reportPublic FDA data

DENTCA Crown and Bridge

Primary DI
00856551007445
Brand
DENTCA Crown and Bridge
Company
DENTCA, INC.
Model
DENTCA Crown and Bridge
Device description
DENTCA Crown and Bridge - B1 - 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
00856551007445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856551007445008565510074458565510074450856551007445

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