FDA.reportPublic FDA data

Morelli

Primary DI
07895742242749
Brand
Morelli
Company
Dental Morelli Ltda
Model
10.13.013
Catalog number
10.13.013
Device description
"Bracket Prescription Roth - SLP .022"" - 34 - Hook"
Published
2021-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07895742242749PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07895742242749078957422427497895742242749

GMDN Terms#

Term, Definition table
TermDefinition
Self-ligating orthodontic bracketA 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 has an integral fixation clip, typically made of a polymer with a metal hinge, to retain the archwire (self-ligating) within a metal insert slot. 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

Contacts#

Phone, Email table
PhoneEmail
+551532388226sac@morelli.com.br

Regulatory Flags#

DUNS number
907156371
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07895742274726Morelli30.45.21630.45.2162026-06-02
07895742290146Morelli37.20.01837.20.0182025-12-01
07895742290153Morelli37.20.01937.20.0192025-12-01
07895742160418Morelli65.05.01465.05.0142021-04-30
07895742292218Morelli65.05.11165.05.1112025-09-23
07895742292232Morelli65.05.11265.05.1122025-09-23
07895742139742Morelli65.05.15665.05.1562021-04-30
07895742154592Morelli65.05.00965.05.0092021-04-30
07895742154608Morelli65.05.10965.05.1092021-04-30
07895742005573Morelli65.05.00165.05.0012021-04-30
07895742005580Morelli65.05.00265.05.0022021-04-30
07895742005597Morelli65.05.00365.05.0032021-04-30
07895742005627Morelli65.05.00665.05.0062021-04-30
07895742005634Morelli65.05.00765.05.0072021-04-30
07895742005641Morelli65.05.00865.05.0082021-04-30
07895742005658Morelli65.05.01065.05.0102021-04-30
07895742005665Morelli65.05.01165.05.0112021-04-30
07895742005672Morelli65.05.01265.05.0122021-04-30
07895742005689Morelli65.05.01365.05.0132021-04-30
07895742064259Morelli65.05.10165.05.1012021-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456205389JMUJMU DENTAL, INCEJF2026-06-25
00840456205396JMUJMU DENTAL, INCEJF2026-06-25
00840456205402JMUJMU DENTAL, INCEJF2026-06-25
00840456205419JMUJMU DENTAL, INCEJF2026-06-25
00840456205914JMUJMU DENTAL, INCEJF2026-06-25
00840456205921JMUJMU DENTAL, INCEJF2026-06-25
00840456205938JMUJMU DENTAL, INCEJF2026-06-25
00840456205945JMUJMU DENTAL, INCEJF2026-06-25
00840456205952JMUJMU DENTAL, INCEJF2026-06-25
00840456205969JMUJMU DENTAL, INCEJF2026-06-25
00840456205976JMUJMU DENTAL, INCEJF2026-06-25
00840456205983JMUJMU DENTAL, INCEJF2026-06-25
00840456205990JMUJMU DENTAL, INCEJF2026-06-25
00840456206003JMUJMU DENTAL, INCEJF2026-06-25
00840456206010JMUJMU DENTAL, INCEJF2026-06-25
00840456206027JMUJMU DENTAL, INCEJF2026-06-25
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
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