FDA.reportPublic FDA data

Temporary CB C2

Primary DI
EBGOFLTCC201US2
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
Dental crown/bridge resin, temporaryA 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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
316483072
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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