FDA.reportPublic FDA data

Temporary CB C2

Primary DI
EBGOFLTCC201US1
Brand
Temporary CB C2
Company
BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG
Model
FLTCC201US
Catalog number
41104US
Published
2020-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K193553000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193553000VarseoSmile TempBego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG2020-05-18EBG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EBGOFLTCC201US2PackageHIBCC1In Commercial Distribution
EBGOFLTCC201US1PrimaryHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Dry

Contacts#

Phone, Email table
PhoneEmail
+4942120280info@bego.com

Regulatory Flags#

DUNS number
316483072
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EBGO505321Mediloy RPD50532505322023-05-12
EBGO50525US1Mediloy Titan Grade 5 SLM Pulver50525US50525US2026-03-24
EBGOBGTQA2011VarseoSmile TriniQBGTQA201BGTQA2012024-09-04
EBGOBGTQA3011VarseoSmile TriniQBGTQA301BGTQA3012024-09-04
EBGOBGTQB1011VarseoSmile TriniQBGTQB101BGTQB1012024-09-04
EBGOSRI02050541SprintRay CrownSRI0205054SRI02050542024-07-31
EBGO50532US1Mediloy RPD50532US50532US2024-07-30
EBGO500061Wiroweld NC50006500062016-09-27
EBGO41177US1VarseoSmile TriniQ41177US41177US2024-02-13
EBGO41178US1VarseoSmile TriniQ41178US41178US2024-02-13
EBGO41179US1VarseoSmile TriniQ41179US41179US2024-02-13
EBGO41187US1VarseoSmile TriniQ41187US41187US2024-02-13
EBGO41188US1VarseoSmile TriniQ41188US41188US2024-02-13
EBGO41189US1VarseoSmile TriniQ41189US41189US2024-02-13
EBGO41170US1VarseoSmile TriniQ41170US41170US2023-12-07
EBGO41171US1VarseoSmile TriniQ41171US41171US2023-12-07
EBGO41172US1VarseoSmile TriniQ41172US41172US2023-12-07
EBGO41173US1VarseoSmile TriniQ41173US41173US2023-12-07
EBGO41174US1VarseoSmile TriniQ41174US41174US2023-12-07
EBGO41175US1VarseoSmile TriniQ41175US41175US2023-12-07

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