FDA.reportPublic FDA data

Morelli

Primary DI
07895742180140
Brand
Morelli
Company
Dental Morelli Ltda
Model
37.20.001
Catalog number
37.20.001
Device description
Toolkit For Orthodontic Miniscrew
Published
2021-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZNINSTRUMENTS, DENTAL HAND

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07895742180140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07895742180140078957421801407895742180140

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, reusableA collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07895742154790Morelli30.40.00930.40.0092021-04-30
07895742160814Morelli35.05.01135.05.0112021-04-30
07895742160821Morelli35.05.01235.05.0122021-04-30
07895742160838Morelli35.05.01335.05.0132021-04-30
07895742169701Morelli30.40.02030.40.0202021-04-30
07895742180614Morelli20.30.24120.30.2412021-04-30
07895742289348Morelli37.20.00337.20.0032024-09-09
07895742260187Morelli10.27.00110.27.0012024-03-27
07895742260361Morelli10.27.00210.27.0022024-03-27
07895742260385Morelli10.27.00310.27.0032024-03-27
07895742260392Morelli10.27.00410.27.0042024-03-27
07895742260408Morelli10.27.00510.27.0052024-03-27
07895742260415Morelli10.27.00610.27.0062024-03-27
07895742260422Morelli10.27.00710.27.0072024-03-27
07895742260439Morelli10.27.00810.27.0082024-03-27
07895742260446Morelli10.27.00910.27.0092024-03-27
07895742260453Morelli10.27.01010.27.0102024-03-27
07895742260460Morelli10.27.01110.27.0112024-03-27
07895742260477Morelli10.27.01210.27.0122024-03-27
07895742260484Morelli10.27.01310.27.0132024-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454000069COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000076COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000083COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000090COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000106COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000113COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001509COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001684COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001691COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001707COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001714COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001721COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001738COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001745COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015315COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015322COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015339COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015346COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015353COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015971COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015988COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000052COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-27
00083208130380Scissors Dean T/C CurvedSuncoast Dental, IncDZN2026-10-07
00816594025448CONTACT MATRIX SYSTEMZest Anchors, LLCDZN2026-10-01
00816594025462CONTACT MATRIX SYSTEMZest Anchors, LLCDZN2026-10-01
00816594025714CONTACT MATRIX SYSTEMZest Anchors, LLCDZN2026-10-01
07908854001750Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2026-09-30
07908854001835Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2026-09-30
07908854018079Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2026-09-30
D955BBGA351Paul BandittTerlain Enterprises, Inc.DZN2026-09-25