FDA.reportPublic FDA data

DENTCA Crown and Bridge for Carbon Printers

Primary DI
00856551007094
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 - BL1 - 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
00856551007094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856551007094008565510070948565510070940856551007094

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
E235DD16A1ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A2ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A35MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A3MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B1ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B3MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL3ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL4MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BLML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BLMN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16C1ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16C1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16C2ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16C2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16D2ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16D2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16D3MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
00371347023398Advance Dental ProductsThe Atlanta Dental Supply CompanyEBG2026-07-08
00371347023404Advance Dental ProductsThe Atlanta Dental Supply CompanyEBG2026-07-08
00371347023411Advance Dental ProductsThe Atlanta Dental Supply CompanyEBG2026-07-08
EPOLPMFLAG5600PMMA CAD/CAM discPOLIDENT d.o.o.EBG2025-05-13
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