FDA.reportPublic FDA data

discovery®

Primary DI
J011718701830
Brand
discovery®
Company
DENTAURUM GmbH & Co.KG
Model
718-701-83
Device description
Assort. discovery® pearl, Roth 18, 13-43 / Brackets / For further information please visit our online-shop on our website www.dentaurum.de
Published
2017-11-09
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
EJFBRACKET, METAL, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJFBracket, Metal, OrthodonticDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K935139000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K935139000FASCINATION CERAMIC BRACKETDentauraum, Inc.1994-02-04EJF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J011718701830PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, ceramicA ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It typically has a metal (e.g., stainless steel) insert slot for the archwire, which is held in place with an orthodontic archwire/bracket fixation ring. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00No special storage conditions required

Contacts#

Phone, Email table
PhoneEmail
+1(800)523-3946info@dentaurum-us.com

Regulatory Flags#

DUNS number
315427286
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J011250001400ceraMotion®250-001-402016-09-15
J011250002200ceraMotion®250-002-202016-09-15
J011250002400ceraMotion®250-002-402016-09-15
J011250003200ceraMotion®250-003-202016-09-15
J011250003400ceraMotion®250-003-402016-09-15
J011250004200ceraMotion®250-004-202016-09-15
J011250004400ceraMotion®250-004-402016-09-15
J011250005200ceraMotion®250-005-202016-09-15
J011250005400ceraMotion®250-005-402016-09-15
J011250006200ceraMotion®250-006-202016-09-15
J011250006400ceraMotion®250-006-402016-09-15
J011250018200ceraMotion®250-018-202016-09-15
J011250019200ceraMotion®250-019-202016-09-15
J011250021200ceraMotion®250-021-202016-09-15
J011250021400ceraMotion®250-021-402016-09-15
J011250022200ceraMotion®250-022-202016-09-15
J011250022400ceraMotion®250-022-402016-09-15
J011250023200ceraMotion®250-023-202016-09-15
J011250023400ceraMotion®250-023-402016-09-15
J011250024200ceraMotion®250-024-202016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10190886271025G&H ORTHODONTICS ®G & H Wire Company, Inc.EJF2026-02-27
10190886271032G&H ORTHODONTICS ®G & H Wire Company, Inc.EJF2026-02-27
10190886271049G&H ORTHODONTICS ®G & H Wire Company, Inc.EJF2026-02-27
10190886271056G&H ORTHODONTICS ®G & H Wire Company, Inc.EJF2026-02-27
10190886271063G&H ORTHODONTICS ®G & H Wire Company, Inc.EJF2026-02-27
10190886271070G&H ORTHODONTICS ®G & H Wire Company, Inc.EJF2026-02-27
10190886271087G&H ORTHODONTICS ®G & H Wire Company, Inc.EJF2026-02-27
10190886271094G&H ORTHODONTICS ®G & H Wire Company, Inc.EJF2026-02-27
10190886271100G&H ORTHODONTICS ®G & H Wire Company, Inc.EJF2026-02-27
10190886271117G&H ORTHODONTICS ®G & H Wire Company, Inc.EJF2026-02-27
07908611216748METAL BRACKET U-CLIP PASSIVE ROTH 0,022 - 1 SETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216755METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U1R (11) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216762METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U2R (12) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216779METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U3R (13) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216786METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U45R (14/15) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216793METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U1L (21) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216809METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U2L (22) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216816METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U3L (23) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216823METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U45L (24/25) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216830METAL BRACKET U-CLIP PASSIVE ROTH 0.022 L12RL (31/32/41/42) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216847METAL BRACKET U-CLIP PASSIVE ROTH 0.022 L3L (33) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216854METAL BRACKET U-CLIP PASSIVE ROTH 0.022 L4L (34) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216861METAL BRACKET U-CLIP PASSIVE ROTH 0.022 L5L (35) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216878METAL BRACKET U-CLIP PASSIVE ROTH 0.022 L3R (43) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216885METAL BRACKET U-CLIP PASSIVE ROTH 0.022 L4R (44) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216892METAL BRACKET U-CLIP PASSIVE ROTH 0.022 L5R (45) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216908METAL BRACKET U-CLIP HYBRID ROTH 0.022 - 1 SETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216939METAL BRACKET U-CLIP PASSIVE MBT 0,022 - 1 SETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216946METAL BRACKET U-CLIP PASSIVE MBT 0.022 U1R (11) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216953METAL BRACKET U-CLIP PASSIVE MBT 0.022 U2R (12) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12