FDA.reportPublic FDA data

Permanent Crown B1

Primary DI
EBGOFLPCB101
Brand
Permanent Crown B1
Company
BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG
Model
FLPCB101US
Published
2020-10-19
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
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201668000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201668000VarseoSmile Crown plusBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG2020-06-23EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EBGOFLPCB101PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental crown, polymerA device made entirely of polymer-based material with or without fibre reinforcement, and created for a specific patient, that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.

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
00348783000931MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000955MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000979MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000993MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783001044MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783001051MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
06975338702916SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338702923SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338702930SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338702947SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338702992SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703005SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703012SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703029SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703074SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703081SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703098SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703104SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703357SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703364SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703371SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703388SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
00348783000917MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-01
D14307560147448040Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147448110Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147448280Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147448350Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147449650Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147450090Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147450160Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29