FDA.report

Morelli

Primary DI
07895742001964
Brand
Morelli
Company
Dental Morelli Ltda
Model
70.31.001
Catalog number
70.31.001
Device description
Headgear for Safety Breakaway Device - Size Small
Published
2021-05-15
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
false

Related Records

Contact Domains

Product Codes

CodeName
KCRFACEBOW

Product Code Classifications

CodeDeviceSpecialtyClass
KCRFacebowDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07895742001964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07895742001964078957420019647895742001964

GMDN Terms

TermDefinition
Orthodontic extraoral headgearA dental device used in conjunction with orthodontic appliances to exert pressure on the teeth or the jaws from outside the mouth. An orthodontic headgear will typically have a strap that wraps around the patient's neck or head and an inner bow portion that is fastened to the orthodontic appliance in the patient's mouth, or utilizes rests on the chin and forehead (reverse pull headgear).

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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07615208460483UTS 3D/ UTS CADIVOCLAR VIVADENT AKTIENGESELLSCHAFTKCR2024-06-26
06973329326059Reverse Pull Headgear(Face Mask), Middle, RedAstar Orthodontics Inc.KCR2023-12-31
06973329326066Reverse Pull Headgear(Face Mask), Middle, BlueAstar Orthodontics Inc.KCR2023-12-31
06973329326073Reverse Pull Headgear(Face Mask), Middle, YellowAstar Orthodontics Inc.KCR2023-12-31
06973329326080Reverse Pull Headgear(Face Mask), Middle, OrangeAstar Orthodontics Inc.KCR2023-12-31
06973329326097Reverse Pull Headgear(Face Mask), Middle, PurpleAstar Orthodontics Inc.KCR2023-12-31
06973329326103Reverse Pull Headgear(Face Mask), Middle, GreenAstar Orthodontics Inc.KCR2023-12-31
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D04020002950Unit-Assy SlidematicWHIP-MIX CORPORATIONKCR2023-10-27
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