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

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
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
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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