FDA.reportPublic FDA data

Tweakz for Braces

Primary DI
00850035489000
Brand
Tweakz for Braces
Company
Orthonu LLC
Model
ORN0001-01
Published
2022-09-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DZNInstruments, Dental Hand

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850035489000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850035489000008500354890008500354890000850035489000

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
125732548
Device count
1
Premarket exempt
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
00850035489055Oral Relief Kitz850035489055ORN0006-012025-04-27
00850035489086Comfort Tape8500354890860RN0007-012025-04-27
00199284539792Comfort Tape™ 199284539792ORN0005-012025-03-22
00199284797581Mouth-Aid1999284797581ORN0005-012025-03-22
00850035489017Tweakz for AlignersORN0002-012022-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454001493COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-11-03
06954454002162COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-11-03
06954454002179COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-11-03
06954454004807COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-11-03
06954454004852COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-11-03
06954454012802COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-11-03
06954454012826COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-11-03
06954454000878COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-11-02
06954454002155COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-11-02
06954454002148COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-31
06954454002445COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-31
06954454003237COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-31
06954454004975COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-31
06954454000069COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000076COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000083COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000090COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000106COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000113COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001509COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001684COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001691COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001707COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001714COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001721COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001738COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001745COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015315COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015322COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015339COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28