FDA.reportPublic FDA data

ADITEK

Primary DI
07899439202528
Brand
ADITEK
Company
ADITEK DO BRASIL S/A
Model
00.00.0002
Device description
Clip Closing Tool
Published
2025-01-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ECPInstrument, Ligature Tucking, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECPInstrument, Ligature Tucking, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899439202528PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899439202528078994392025287899439202528

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic appliance dimension gaugeA dental instrument intended to be used for accurate measurement of the dimensions of an orthodontic appliance (e.g., orthodontic bracket height) especially as it relates to patient oral anatomy during the fitting of the appliance (e.g., determining distance from the incisal edge to an orthodontic bracket locator blade). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
900761396
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899439204300ADITEK16.38.0004.216.38.0004.22025-09-22
07899439204317ADITEK16.38.0005.116.38.0005.12025-09-22
07899439216471ADITEK16.38.0005.616.38.0005.62025-09-22
07899439219496ADITEK16.38.0009.2 16.38.0009.2 2025-09-22
07899439219502ADITEK16.38.0009.1 16.38.0009.1 2025-09-22
07899439220317ADITEK16.38.0010.116.38.0010.12025-09-22
07899439239661ADITEK09.23.0512 2025-01-21
07899439239678ADITEK09.23.0514 2025-01-21
07899439239685ADITEK09.23.05162025-01-21
07899439239692ADITEK09.23.0518 2025-01-21
07899439239708ADITEK09.23.0520 2025-01-21
07899439239715ADITEK09.23.0525 2025-01-21
07899439239722ADITEK09.23.0562 2025-01-21
07899439239739ADITEK09.23.0566 2025-01-21
07899439239746ADITEK09.23.0575 2025-01-21
07899439239753ADITEK09.23.0585 2025-01-21
07899439239760ADITEK09.23.0595 2025-01-21
07899439239777ADITEK09.23.0612 2025-01-21
07899439239784ADITEK09.23.0614 2025-01-21
07899439239791ADITEK09.23.06162025-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB1360TBS BASICSACME ENTERPRISE.ECP2026-05-20
G149TBSB1350TBS BASICSACME ENTERPRISE.ECP2026-05-18
00840479203614ULTRA VIOLET MINI LIGHTRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-13
00840479203669SYRINGE WING (1)RELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-13
00840479203270MIXING RESERVOIR RING WELRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-12
00840479203287MIXING RESERVOIR RING WELRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-12
00840479203348SPATULARELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-12
00840479203447SPONGE PELLETRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-12
00840479202112MICROBRUSHRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-10
00840479202143MICROBRUSHRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-10
00840479202150MICROBRUSHRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-10
00840479202167MIXING ACCESSORY PACKRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-10
00840479201528SYRINGE WING (1)RELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-05
00840479200576SPATULARELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200583WHITE SCOOPRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200590LIGHT IMPERVIOUS MIX WELLRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200606SUPERFINE MICROBRUSHRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200651SPONGE PELLETRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
0084047920070521 GAUGE BRUSH TIPSRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200712"4"" BEND A BRUSHES"RELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200729"4"" BEND A BRUSHES"RELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200743ACCESSORY PACKRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200972BRUSH TIPSRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200354WHITE MIXING WELLRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-20
00840479200361CLEAR SCOOPRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-20
00840479200385CLEAR SCOOPRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-20
00840479200866BRUSH HANDLE ASSORTEDRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-20
00840479203454SELF MIXING TIPSRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-20
0084047920349215 GAUGE TIPSRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-20
00840479209814SELF MIXING TIPSRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-20