FDA.reportPublic FDA data

Ortho Shop

Primary DI
10810152071660
Brand
Ortho Shop
Company
Orthoshop, LLC
Model
9202
Catalog number
9202
Device description
Crimpable Split Stops
Published
2023-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
ECNClamp, Wire, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECNClamp, Wire, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810152071663PrimaryGS10
10810152071660Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810152071663008101520716638101520716630810152071663
1081015207166010810152071660

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic lockA dental device intended to be placed on an orthodontic archwire or rod via screwing, crimping, or soldering, for orthodontic spring activation and/or to prevent the archwire from sliding within the brackets. It may be designed in various forms (e.g., Gurin lock, stop). It does not incorporate a pin or hook. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
129808388
Device count
10
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
true
Expiration date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810152070007Mini Maxx S 1011-22-553451011-22-553452023-11-24
10810152070014Mini Maxx S 1011-22-5531011-22-5532023-11-24
10810152070021Mini Maxx S 1011-18-553451011-18-553452023-11-24
10810152070038Mini Maxx S 1011-18-5531011-18-5532023-11-24
10810152070045Lucchesi Sub-Slot2011-22-553452011-22-553452023-11-24
10810152070052ICON 3034-22-5533034-22-5532023-11-24
10810152070069ICON 3034-22-553453034-22-553452023-11-24
10810152070076Mini Maxx S 1011-22-111011-22-112023-11-24
10810152070083Mini Maxx S 1011-22-211011-22-212023-11-24
10810152070090Mini Maxx S 1011-22-121011-22-122023-11-24
10810152070106Mini Maxx S 1011-22-221011-22-222023-11-24
10810152070113Mini Maxx S 1011-22-13H1011-22-13H2023-11-24
10810152070120Mini Maxx S 1011-22-23H1011-22-23H2023-11-24
10810152070137Mini Maxx S 1011-22-14H1011-22-14H2023-11-24
10810152070144Mini Maxx S 1011-22-141011-22-142023-11-24
10810152070151Mini Maxx S 1011-22-24H1011-22-24H2023-11-24
10810152070168Mini Maxx S 1011-22-241011-22-242023-11-24
10810152070175Mini Maxx S 1011-22-15H1011-22-15H2023-11-24
10810152070182Mini Maxx S 1011-22-151011-22-152023-11-24
10810152070199Mini Maxx S 1011-22-25H1011-22-25H2023-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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