FDA.reportPublic FDA data

VarseoSmile TriniQ

Primary DI
EBGO41177US1
Brand
VarseoSmile TriniQ
Company
BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG
Model
41177US
Catalog number
41177US
Published
2024-02-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin
EBGCrown And Bridge, Temporary, Resin
PZYAdditively Manufactured, Preformed, Resin Denture Tooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2
EBGCrown And Bridge, Temporary, ResinDental2
PZYAdditively Manufactured, Preformed, Resin Denture ToothDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233596000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233596000VarseoSmile TriniQBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG2023-11-09EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EBGO41177US1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made dental crown, polymerA device made entirely of polymer-based material with or without fibre reinforcement, and created for a specific post-pubescent/adult patient (custom-made), 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
Handling Environment Temperature18 Degrees Celsius35 Degrees Celsius
Storage Environment Temperature4 Degrees Celsius35 Degrees Celsius

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
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
EBGO41176US1VarseoSmile TriniQ41176US41176US2023-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806383591676DIAFIL Bulk FLOWDiaDent Group InternationalEBF2026-07-24
08806383591720DIAFIL Bulk FLOWDiaDent Group InternationalEBF2026-07-24
08806383591911DIAFIL Bulk FLOWDiaDent Group InternationalEBF2026-07-24
00840456224373JMUJMU DENTAL, INCEBF2026-07-22
00840456224380JMUJMU DENTAL, INCEBF2026-07-22
00840456224397JMUJMU DENTAL, INCEBF2026-07-22
00840456224403JMUJMU DENTAL, INCEBF2026-07-22
00840456224410JMUJMU DENTAL, INCEBF2026-07-22
07506338322478Nic ToneMDC DENTALEBG2026-07-20
07506338322485VIVIDMDC DENTALEBG2026-07-20
07506338322492VIVIDMDC DENTALEBG2026-07-20
07506338322508VIVIDMDC DENTALEBG2026-07-20
07506338322515VIVIDMDC DENTALEBG2026-07-20
07506338322522VIVIDMDC DENTALEBG2026-07-20
07506338322539VIVIDMDC DENTALEBG2026-07-20
07506338322546VIVIDMDC DENTALEBG2026-07-20
07506338322553VIVIDMDC DENTALEBG2026-07-20
07506338322560VIVIDMDC DENTALEBG2026-07-20
07506338322577Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
07506338322584Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
07506338322591Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
07506338322614Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
07506338322973Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
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