FDA.report

Morelli

Primary DI
07895742007409
Brand
Morelli
Company
Dental Morelli Ltda
Model
10.30.208
Catalog number
10.30.208
Device description
Bracket Prescription Edgewise - Standard .022" - 13, 14, 15, 23, 24, 25, 33, 34, 35, 43, 44, 45
Published
2021-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EJFBRACKET, METAL, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EJFBracket, Metal, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07895742007409PrimaryGS10

GMDN Terms

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

Contacts

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 DIBrandModelCatalogPublished
07895742290146Morelli37.20.01837.20.0182025-12-01
07895742290153Morelli37.20.01937.20.0192025-12-01
07895742292218Morelli65.05.11165.05.1112025-09-23
07895742292232Morelli65.05.11265.05.1122025-09-23
07895742289096Morelli30.40.05030.40.0502025-05-28
07895742289102Morelli30.40.05130.40.0512025-05-28
07895742245542Morelli75.01.15275.01.1522025-04-08
07895742245559Morelli75.01.15375.01.1532025-04-08
07895742245566Morelli75.01.15475.01.1542025-04-08
07895742288501Morelli37.10.21037.10.2102025-02-11
07895742288570Morelli37.10.60337.10.6032025-02-11
07895742274023Morelli10.15.72310.15.7232024-12-09
07895742274030Morelli10.15.72510.15.7252024-12-09
07895742286729Morelli20.13.90020.13.9002024-12-06
07895742289904Morelli30.06.30430.06.3042024-09-27
07895742275297Morelli30.06.30330.06.3032024-09-24
07895742285982Morelli50.14.90250.14.9022024-09-23
07895742289348Morelli37.20.00337.20.0032024-09-09
07895742289355Morelli37.20.01737.20.0172024-09-09
07895742285999Morelli50.14.90050.14.9002024-09-02

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