FDA.reportPublic FDA data

Aligner Treatment Starter Kitz

Primary DI
00850035489079
Brand
Aligner Treatment Starter Kitz
Company
Orthonu LLC
Model
0850035489
Catalog number
ORN0006-03
Device description
A Kit with 5 products including Tweakz for Aligners, comfort tape, mouth-aid, OrthoChewz and Chillin’ Strips.
Published
2025-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NYCDental Prophylaxis Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NYCDental Prophylaxis KitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850035489079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850035489079008500354890798500354890790850035489079

GMDN Terms#

Term, Definition table
TermDefinition
Dental restoration/appliance emergency fix kitA convenient collection of the necessary equipment and materials, typically used in an emergency by a layperson, to refix a dental restoration or appliance. It is typically used to temporarily refix dislodged crowns, bridges, fillings, or inlays to restore appearance and function without professional assistance. It typically consists of dental adhesive materials and mixing and application utensils. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9175965065sima@orthonu.com

Regulatory Flags#

DUNS number
125732548
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850035489062Braces Treatment Starter Kitz0850035489ORN0006-022025-06-04
00850035489031Mouth-Aid850035489031ORN0005-012025-04-27
00850035489055Oral Relief Kitz850035489055ORN0006-012025-04-27
00850035489086Comfort Tape8500354890860RN0007-012025-04-27
00199284539792Comfort Tape™ 199284539792ORN0005-012025-03-22
00199284797581Mouth-Aid1999284797581ORN0005-012025-03-22
00850035489000Tweakz for BracesORN0001-012022-09-19
00850035489017Tweakz for AlignersORN0002-012022-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05010058078147InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058081406InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058081666InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058084582InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058084599InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058084605InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058178144InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058181403InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058181663InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058184589InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058184596InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058184602InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-23
05010058081673InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-19
05010058181670InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-06-19
00850035489062Braces Treatment Starter KitzOrthonu LLCNYC2025-06-04
05010058078123InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-05-21
05010058178120InstrapacROBINSON HEALTHCARE LIMITEDNYC2025-05-21
05010058070158InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
05010058071230InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
05010058071414InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
05010058088788InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
05010058088849InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
05010058170155InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
05010058171237InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
05010058171411InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
05010058188785InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
05010058188846InstrapacROBINSON HEALTHCARE LIMITEDNYC2023-08-08
06970873260297Root Canal Instruments KitDENJOY DENTAL CO.,LTDNYC2022-02-19
D746ORX000051SureSmile®DENTSPLY SIRONA ORTHODONTICS INC.NYC2021-12-16