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
06942201775735FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-15
06942201776015FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-15
06942201776206FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-15
00810222900206SprintRay Crown HT A1 Single-Unit Capsule - JapanSprintray, Inc.EBG2026-10-09
00810222900213SprintRay Crown HT A2 Single-Unit Capsule - JPSprintray, Inc.EBG2026-10-09
00810222900220SprintRay Crown HT Bleach Single-Unit Capsule - JPSprintray, Inc.EBG2026-10-09
00810222900237SprintRay Crown HT B1 Single-Unit Capsule - JPSprintray, Inc.EBG2026-10-09
00810222900244SprintRay Crown HT B1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBG2026-10-09
00810222900251SprintRay Crown HT Bleach Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBG2026-10-09
00810222900268SprintRay Crown HT A3 Single-Unit Capsule - JPSprintray, Inc.EBG2026-10-09
00810222900275SprintRay Crown HT A3 Single-unit Capsule 3-Pack - JPSprintray, Inc.EBG2026-10-09
00810222900282SprintRay Crown HT Unpigmented Single-Unit Capsule - JPSprintray, Inc.EBG2026-10-09
00810222900299SprintRay Crown HT Unpigmented Single-unit Capsule 3-Pack - JPSprintray, Inc.EBG2026-10-09
00810222900305SprintRay Crown HT A1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBG2026-10-09
00810222900312SprintRay Crown HT A2 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBG2026-10-09
00197998226724Solventum™ Protemp™Solventum Germany GmbHEBG2026-10-08
00197998226731Solventum™ Protemp™Solventum Germany GmbHEBG2026-10-08
00197998226748Solventum™ Protemp™Solventum Germany GmbHEBG2026-10-08
00197998226755Solventum™ Protemp™Solventum Germany GmbHEBG2026-10-08
00197998226762Solventum™ Protemp™Solventum Germany GmbHEBG2026-10-08
00197998226779Solventum™ Protemp™Solventum Germany GmbHEBG2026-10-08
00197998226786Solventum™ Protemp™Solventum Germany GmbHEBG2026-10-08
00197998226809Solventum™ Paradigm™Solventum Germany GmbHEBG2026-10-08
00197998226816Solventum™ Paradigm™Solventum Germany GmbHEBG2026-10-08
00197998226823Solventum™ Paradigm™Solventum Germany GmbHEBG2026-10-08
06942201762285FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201762377FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201762476FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774288FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774387FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05