FDA.reportPublic FDA data

Morelli

Primary DI
07895742002749
Brand
Morelli
Company
Dental Morelli Ltda
Model
75.01.007
Catalog number
75.01.007
Device description
Band Marker 5.0 - 4.5 - 4.0 - 3.5 mm
Published
2021-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ECRSETTER, BAND, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECRSetter, Band, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07895742002749PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07895742002749078957420027497895742002749

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic elastomeric appliance pusherA hand-held device intended to be used by laypersons to remove/apply orthodontic elastomeric appliances (e.g., inter-arch bands, inter-bracket chains) from/to orthodontic brackets. It is typically a thin plastic device with a hook on one end and a pusher on the other, intended to be used by a patient in the home (e.g., before and after eating or sleep). This is a single-use 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
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07895742139742Morelli65.05.15665.05.1562021-04-30
07895742188795Morelli60.05.32860.05.3282021-04-30
07895742188818Morelli60.05.31660.05.3162021-04-30
07895742188849Morelli60.05.32260.05.3222021-04-30
07895742188740Morelli60.05.21360.05.2132021-04-30
07895742274726Morelli30.45.21630.45.2162026-06-02
07895742274023Morelli10.15.72310.15.7232024-12-09
07895742274030Morelli10.15.72510.15.7252024-12-09
07895742280901Morelli10.23.93510.23.9352024-03-26
07895742282103Morelli10.16.00110.16.0012023-11-14
07895742282110Morelli10.16.00210.16.0022023-11-14
07895742282127Morelli10.16.00310.16.0032023-11-14
07895742282134Morelli10.16.00410.16.0042023-11-14
07895742282141Morelli10.16.00510.16.0052023-11-14
07895742282158Morelli10.16.00610.16.0062023-11-14
07895742282165Morelli10.16.00710.16.0072023-11-14
07895742282172Morelli10.16.00810.16.0082023-11-14
07895742282189Morelli10.16.00910.16.0092023-11-14
07895742282196Morelli10.16.01010.16.0102023-11-14
07895742282202Morelli10.16.01110.16.0112023-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014476143SmileSet Aligner/Retainer Seater/Removal ToolOrtho Dental Lab LLCECR2025-10-16
00850078989321SmileSet Aligner/Retainer Seater/Removal Tool – 4 PackOrtho Dental Lab LLCECR2025-10-01
00889813063699Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCECR2024-11-30
00813677022967PDT, Inc.PDT, INC.ECR2024-07-05
00813677022974PDT, Inc.PDT, INC.ECR2024-07-05
00840326420836Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
00840326420843Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
00840326420928Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
00840326420935Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
00840326420942Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
00840326420959Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420833Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420840Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420925Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420932Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420949Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420956Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
D1272421031Artman Instruments Wise Linkers, LLCECR2023-03-28
E89656540SCHWERTA. Schweickhardt GmbH & Co. KGECR2023-03-07
E8965654500SCHWERTA. Schweickhardt GmbH & Co. KGECR2023-03-07
E896495010SCHWERTA. Schweickhardt GmbH & Co. KGECR2023-03-06
00817524028805J&J InstrumentsJ & J INSTRUMENTS INCECR2023-03-01
00817524028812J&J InstrumentsJ & J INSTRUMENTS INCECR2023-03-01
00850007728410ALIGNER SEATER PURPLEAccess Dental Lab, LLCECR2023-02-17
EZPF19080120HELMUT ZEPFHelmut Zepf Medizintechnik GmbHECR2022-11-29
EZPF1926200WL0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHECR2022-11-25
00840326408773OrthoquestYoung Innovations, Inc.ECR2022-11-03
00840326408803OrthoquestYoung Innovations, Inc.ECR2022-11-03
10840326408770OrthoquestYoung Innovations, Inc.ECR2022-11-03
10840326408800OrthoquestYoung Innovations, Inc.ECR2022-11-03