FDA.report

ORTHOMETRIC STOP

Primary DI
07908470705728
Brand
ORTHOMETRIC STOP
Company
ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
Model
30.10.2021
Catalog number
30.10.2021
Device description
ARCHWIRE OPEN STOP ROUND
Published
2022-09-27
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
true

Related Records

Product Codes

CodeName
ECNClamp, Wire, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
ECNClamp, Wire, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07908470705728PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07908470705728079084707057287908470705728

GMDN Terms

TermDefinition
Orthodontic clasp, metal, preformedA prefabricated dental device made of wrought metal alloy intended to retain and stabilize a removable orthodontic appliance to stationary teeth. It is manufactured to meet a standard specification for adaptation or direct insertion into the patient's mouth. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods

Method

Regulatory Flags

DUNS number
898330003
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
07898488904056METAL BRACKET ADVANCED ROTH 0.022 - U1R (11) - 100UN10.10.23112026-05-26
07898488904063METAL BRACKET ADVANCED ROTH 0.022 - U2R (12) - 100UN10.10.23122026-05-26
07898488904070METAL BRACKET ADVANCED ROTH 0.022 - U3R (13) - 100UN10.10.23132026-05-26
07898488904087METAL BRACKET ADVANCED ROTH 0.022 - U45R (14,15) - 100UN10.10.23142026-05-26
07898488904094METAL BRACKET ADVANCED ROTH 0.022 - U1L (21) - 100UN10.10.23212026-05-26
07898488904100METAL BRACKET ADVANCED ROTH 0.022 - U2L (22) - 100UN10.10.23222026-05-26
07898488904117METAL BRACKET ADVANCED ROTH 0.022 - U3L (23) - 100UN10.10.23232026-05-26
07898488904124METAL BRACKET ADVANCED ROTH 0.022 - U45L (24,25) - 100UN10.10.23242026-05-26
07898488904148METAL BRACKET ADVANCED ROTH 0.022 - L3L (33) - 100UN10.10.23332026-05-26
07898488904155METAL BRACKET ADVANCED ROTH 0.022 - L4L (34) - 100UN10.10.23342026-05-26
07898488904162METAL BRACKET ADVANCED ROTH 0.022 - L5L (35) - 100UN10.10.23352026-05-26
07898488904179METAL BRACKET ADVANCED ROTH 0.022 - L3R (43) - 100UN10.10.23432026-05-26
07898488904186METAL BRACKET ADVANCED ROTH 0.022 - L4R (44) - 100UN10.10.23442026-05-26
07898488904193METAL BRACKET ADVANCED ROTH 0.022 - L5R (45) - 100UN10.10.23452026-05-26
07908470701294STAINLESS STEEL - WIRE ROUND 0.014 - UPPER - 12UN51.60.20142026-05-26
07908470701355STAINLESS STEEL - WIRE RECTANGULAR 0.019X0.025 - UPPER - 12UN51.60.25192026-05-26
07908470707678KIT LAUNCH - U-CLIP10.45.23012026-05-26
07908470708798KIT ARCHWIRE SEQUENCE HEAVY51.35.28032026-05-26
07908611202772CERAMIC BRACKET ICERAM MBT 0.022 L5R (45) - 1UN10.84.22452026-05-26
07908611204103CERAMIC MINI TUBE -10UN21.02.20042026-05-26

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840479201399EXTEND LINGUAL WIRESRELIANCE ORTHODONTIC PRODUCTS INCECN2026-03-05
00840479201405EXTEND MEASURING DEVICERELIANCE ORTHODONTIC PRODUCTS INCECN2026-03-05
00840479201412EXTEND LINGUAL WIRESRELIANCE ORTHODONTIC PRODUCTS INCECN2026-03-05
00840479201429EXTEND LINGUAL WIRESRELIANCE ORTHODONTIC PRODUCTS INCECN2026-03-05
00840479201436EXTEND LINGUAL WIRESRELIANCE ORTHODONTIC PRODUCTS INCECN2026-03-05
00840479201443EXTEND LINGUAL WIRESRELIANCE ORTHODONTIC PRODUCTS INCECN2026-03-05
00840479201450EXTEND LINGUAL WIRESRELIANCE ORTHODONTIC PRODUCTS INCECN2026-03-05
00810126381118Nance - Hor RemDigital Dental Laboratories, IncECN2026-02-26
00810126381019Adapt ApplianceDigital Dental Laboratories, IncECN2026-02-25
00810126381026Alf applianceDigital Dental Laboratories, IncECN2026-02-25
00810126381033BiofinisherDigital Dental Laboratories, IncECN2026-02-25
00810126381040Bionator/ActivatorDigital Dental Laboratories, IncECN2026-02-25
00810126381057FraenkelDigital Dental Laboratories, IncECN2026-02-25
00810126381064Habit breaker - removableDigital Dental Laboratories, IncECN2026-02-25
00810126381071HomeoblockDigital Dental Laboratories, IncECN2026-02-25
00810126381088Lingual Arch - Hor remDigital Dental Laboratories, IncECN2026-02-25
00810126381095Lingual Arch - SolderedDigital Dental Laboratories, IncECN2026-02-25
00810126381101Linguarl Arch - Vert RemDigital Dental Laboratories, IncECN2026-02-25
00810126381125Nance - solderedDigital Dental Laboratories, IncECN2026-02-25
00810126381132Nance - Vert RemDigital Dental Laboratories, IncECN2026-02-25
00810126381149OD1Digital Dental Laboratories, IncECN2026-02-25
00810126381156OD2Digital Dental Laboratories, IncECN2026-02-25
00810126381163OD3Digital Dental Laboratories, IncECN2026-02-25
00810126381170OD4Digital Dental Laboratories, IncECN2026-02-25
00810126381187ON1Digital Dental Laboratories, IncECN2026-02-25
00810126381194ON2Digital Dental Laboratories, IncECN2026-02-25
00810126381200ON3Digital Dental Laboratories, IncECN2026-02-25
00810126381217ON4Digital Dental Laboratories, IncECN2026-02-25
00810126381224ON5Digital Dental Laboratories, IncECN2026-02-25
00810126381231PerfectorDigital Dental Laboratories, IncECN2026-02-25