FDA.reportPublic FDA data

Morelli

Primary DI
07895742242619
Brand
Morelli
Company
Dental Morelli Ltda
Model
10.13.003
Catalog number
10.13.003
Device description
Bracket Prescription Roth - SLP .022" - 12
Published
2021-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
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
07895742242619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07895742242619078957422426197895742242619

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.

Contacts#

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

Regulatory Flags#

DUNS number
907156371
Device count
1
DM exempt
false
Premarket exempt
true
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
07895742139742Morelli65.05.15665.05.1562021-04-30
07895742188795Morelli60.05.32860.05.3282021-04-30
07895742188818Morelli60.05.31660.05.3162021-04-30
07895742188849Morelli60.05.32260.05.3222021-04-30
07895742188740Morelli60.05.21360.05.2132021-04-30
07895742274726Morelli30.45.21630.45.2162026-06-02
07895742274023Morelli10.15.72310.15.7232024-12-09
07895742274030Morelli10.15.72510.15.7252024-12-09
07895742280901Morelli10.23.93510.23.9352024-03-26
07895742282103Morelli10.16.00110.16.0012023-11-14
07895742282110Morelli10.16.00210.16.0022023-11-14
07895742282127Morelli10.16.00310.16.0032023-11-14
07895742282134Morelli10.16.00410.16.0042023-11-14
07895742282141Morelli10.16.00510.16.0052023-11-14
07895742282158Morelli10.16.00610.16.0062023-11-14
07895742282165Morelli10.16.00710.16.0072023-11-14
07895742282172Morelli10.16.00810.16.0082023-11-14
07895742282189Morelli10.16.00910.16.0092023-11-14
07895742282196Morelli10.16.01010.16.0102023-11-14
07895742282202Morelli10.16.01110.16.0112023-11-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190707193034Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193041Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193058Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193065Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193072Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193089Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193096Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193102Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193119Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193126Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
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