FDA.report

Morelli

Primary DI
07895742019426
Brand
Morelli
Company
Dental Morelli Ltda
Model
35.05.001
Catalog number
35.05.001
Device description
Gurin Round and Closed Slot
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

Contact Domains

Product Codes

CodeName
EJFBRACKET, METAL, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EJFBracket, Metal, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07895742019426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07895742019426078957420194267895742019426

GMDN Terms

TermDefinition
Orthodontic lockA dental device intended to be placed on an orthodontic archwire or rod via screwing, crimping, or soldering, for orthodontic spring activation and/or to prevent the archwire from sliding within the brackets. It may be designed in various forms (e.g., Gurin lock, stop). It does not incorporate a pin or hook. This is a single-patient device that is 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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00190746191602Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
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00190746191640Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191657Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191664Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191671Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191688Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191695Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191701Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191718Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191725Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191732Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191749Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191756Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191763Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191770Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191787Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191794Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191800Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191817Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191824Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191831Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191848Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191855Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191862Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191879Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191886Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191893Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23