FDA.reportPublic FDA data

Oral Relief Kitz

Primary DI
00850035489055
Brand
Oral Relief Kitz
Company
Orthonu LLC
Model
850035489055
Catalog number
ORN0006-01
Device description
A Kit with 4 products including comfort tape, mouth-aid, OrthoChewz and Chillin’ Strips.
Published
2025-04-27
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
NXZDental Hygiene Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXZDental Hygiene KitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850035489055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850035489055008500354890558500354890550850035489055

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9175965065sima@orthonu.com

Regulatory Flags#

DUNS number
125732548
Device count
1
Premarket exempt
true
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
00850035489079Aligner Treatment Starter Kitz0850035489ORN0006-032025-06-04
00850035489031Mouth-Aid850035489031ORN0005-012025-04-27
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
06956748709443Angel AlignerWuxi EA Medical Instruments Technologies Limited.NXZ2026-02-04
B23931150Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2026-01-08
B23931151Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2026-01-08
B23930870Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-09-09
B23930871Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-09-09
B23931080Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-08-12
B23931081Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-08-12
B23931060Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-08-05
B23931070Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-08-05
B23931061Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-08-05
B23931071Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-08-05
B23930020Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-18
B23931020Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-18
B23931050Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-18
B23930021Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-18
B23931021Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-18
B23931051Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-18
B23930900Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-02
B23931040Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-02
B23930901Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-02
B23931041Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-02
B23931030Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-06-21
B23931031Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-06-21
B23930730Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-04-17
B23930940Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-04-17
B23930950Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-04-17
B23930731Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-04-17
B23930941Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-04-17
B23930951Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-04-17
B23930880Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-02-20