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

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
08404535030822Brasseler USAPeter Brasseler Holdings, LLCNYC2026-07-13
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