FDA.report

Morelli

Primary DI
07895742288570
Brand
Morelli
Company
Dental Morelli Ltda
Model
37.10.603
Catalog number
37.10.603
Device description
Extrarradicular Orthodontic Steel Mini Screw - Hole .021 x .025" (Leng.: 10mm - Transm.: 6mm - Ø2mm)
Published
2025-02-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OATImplant, endosseous, orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
OATImplant, Endosseous, OrthodonticDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07895742288570PrimaryGS10

GMDN Terms

TermDefinition
Orthodontic anchoring screwA small, metallic, implantable rod with a spiral thread and slotted/formed head that is inserted into the bone of the jaw to serve as a temporary anchor for an orthodontic device (e.g., a spring or plate). It is available in various sizes and lengths, and may have a self-drilling/self-tapping thread for easy insertion and removal after desired alignment of the teeth. It is used in a variety of orthodontic treatment situations, especially when normal anatomy has been compromised (e.g., due to periodontal disease or agenesis, displacement of teeth in the same direction, asymmetrical anatomy). This is a single-use device.

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
+551532388226sac@morelli.com.br

Regulatory Flags

DUNS number
907156371
Device count
1
DM exempt
false
Premarket exempt
false
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
true

Other Devices From This Company

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07895742292218Morelli65.05.11165.05.1112025-09-23
07895742292232Morelli65.05.11265.05.1122025-09-23
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07895742289102Morelli30.40.05130.40.0512025-05-28
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07895742245559Morelli75.01.15375.01.1532025-04-08
07895742245566Morelli75.01.15475.01.1542025-04-08
07895742288501Morelli37.10.21037.10.2102025-02-11
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
07895742280963Morelli75.01.14375.01.1432024-08-07

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