FDA.reportPublic FDA data

Vatech Clismile

Primary DI
08800018601242
Brand
Vatech Clismile
Company
Rayence Co., Ltd.
Model
22-1235
Device description
This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
Published
2022-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EJFBracket, Metal, Orthodontic

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800018601242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800018601242088000186012428800018601242

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, metalA metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
557804458
Device count
1
Premarket exempt
true
Combination product
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
088000186022562430TCA2430TCA2025-04-08
088000186022181717WCE1717WCE2024-09-19
088000186022251717WCE-HR1717WCE-HR2024-09-19
088000186022321717WCE-HS1717WCE-HS2024-09-19
088000186022491717WCE-GF1717WCE-GF2024-09-19
088000186021950909FCC0909FCC2024-03-21
088000186022010909FCC-HS0909FCC-HS2024-03-21
088000186021401417WCE1417WCE2023-06-29
088000186021571417WCE-HR1417WCE-HR2023-06-29
088000186021641417WCE-HS1417WCE-HS2023-06-29
088000186021711417WCE-GF1417WCE-GF2023-06-29
08800018600924Vatech Clismile11-12112022-05-31
08800018600931Vatech Clismile 11-12212022-05-31
08800018600948Vatech Clismile 11-12122022-05-31
08800018600955Vatech Clismile 11-12222022-05-31
08800018600962Vatech Clismile 11-12132022-05-31
08800018600979Vatech Clismile 11-12232022-05-31
08800018600986Vatech Clismile 11-12142022-05-31
08800018600993Vatech Clismile 11-12152022-05-31
08800018601006Vatech Clismile 11-12242022-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013236601VECS Palate ExpanderAZURE MICRODYNAMICS, INC.EJF2026-06-05
00860013236618VECS Palate ExpanderAZURE MICRODYNAMICS, INC.EJF2026-06-05
00860013236625VECS Lab KitAZURE MICRODYNAMICS, INC.EJF2026-06-05
00860013236632VECS Activation KeyAZURE MICRODYNAMICS, INC.EJF2026-06-05
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
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