FDA.reportPublic FDA data

Freddy

Primary DI
07333117000087
Brand
Freddy
Company
Gestenco International AB
Model
FCB-00-01
Catalog number
FCB-00-01
Published
2020-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DYWBracket, Plastic, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYWBracket, Plastic, OrthodonticDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053055000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053055000ORTHODONTIC POLYMER COMPOSITE BRACKETGestenco International AB2005-12-22DYW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07333117000087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333117000087073331170000877333117000087

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, plastic, single-useA plastic device intended to be bonded to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
354936098
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07333117000193Mark VI IPR Gauge setMK-00-012026-04-30
07333117010000Rodney Aligner Seaters, mintRAS-0012026-04-30
07333117010017Rodney Aligner Seaters, lemonRAS-0022026-04-30
07333117010024Rodney Aligner Seaters, melonRAS-0032026-04-30
07333117010369Rodney Aligner SeatersRAS-0042026-04-30
07333117000032SmartBondSM-002SM-0022020-10-15
07333117000049SmartBondSM-001SM-0012020-10-15
07333117000056SmartBond LCSM-100-LCSM-100-LC2020-10-15
07333117000063SmartBond LCSM-300-LCSM-300-LC2020-10-15
07333117000223FreddyFCB-00-01HKFCB-00-01HK2020-10-14
07333117000018SmartBondSM-000SM-0002016-10-11
07333117000025SmartBondSM-010SM-0102016-10-11
07333117000216SpringtimeKITSP-55-55HKSKITSP-55-55HKS2017-01-13
07333117000070Bite-BumperBB-00-01BB-00-012016-10-11
07333117000148Cheek retractorCR-00-01CR-00-012020-10-15
07333117000162Lip RetractorLR-00-01LR-00-012020-10-15
07333117000179Lip RetractorLR-00-02LR-00-022020-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D8294104C1Premium LineEC Certification Service GmbHDYW2026-07-09
D8294210TL1Premium LineEC Certification Service GmbHDYW2026-07-09
D8294210TLE1Premium LineEC Certification Service GmbHDYW2026-07-09
D8294221C1Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102721000051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102721000101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102721000501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102821000051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102821000101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102821000501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102821900051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102821900101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102821900501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103120000051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103120000101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103120000501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103120900051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103120900101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103120900501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103121000051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103121000101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103121000501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103121900051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103121900101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103121900501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103220000051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103220000101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103220000501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103220900051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103220900101Premium LineEC Certification Service GmbHDYW2026-07-09