FDA.reportPublic FDA data

ITL Dental

Primary DI
00817686027029
Brand
ITL Dental
Company
EMERY ENTERPRISES INC
Model
IHAW3211A
Device description
IHAW3211A 3.2 X 11.5MM WP, HA IMPLANT CERVICAL CONTOUR
Published
2021-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817686027029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817686027029008176860270298176860270290817686027029

GMDN Terms#

Term, Definition table
TermDefinition
Amphetamine/methamphetamine group IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of the amphetamine and/or methamphetamine group(s) [e.g., 3,4-methylenedioxymethamphetamine (MDMA), also known as ecstasy] in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses. It is not intended for self-testing.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
836292029
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817686020006ITLDentalSMS-60312024-03-29
00817686023779ITLDentalSMS-60332024-03-29
00817686023830ITLDentalGTW-302024-03-29
00817686023854ITLDentalGTW 352024-03-29
00817686024066ITLDentalH-25L2024-03-29
00817686024295ITLDentalH-25LS2024-03-29
00817686024301ITLDentalH-25LL2024-03-29
00817686025704ITLDentalSMS-60342024-03-29
00817686029009ITLDentalATWS2024-03-29
00817686029016ITLDentalBEK-22024-03-29
00817686029023ITLDentalGTW-35D2024-03-29
00817686029047ITLDentalTSU-10432024-03-29
00817686029054ITLDentalTSU-10552024-03-29
00817686029085ITLDentalSMS-00312024-03-29
00817686029092ITLDentalSMS-00322024-03-29
00817686029108ITLDentalSMS-00332024-03-29
00817686029115ITLDentalSMS-00342024-03-29
00817686029122ITLDentalSBT-10562024-03-29
00817686029139ITLDentalSDAS-10572024-03-29
00817686029146ITLDentalSMU-50222024-03-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800070230008ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-07-29
08800070201619ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-07-27
08800070218600ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-07-27
08800070218891ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-07-27
08800070228333ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-07-27
00810126046871ET III Fixture SA Regular No MountHIOSSEN, INC.DZE2026-07-14
07290112780010Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780522Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780645Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780652Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781215Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781222Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781246Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781260Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781284Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781710Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781727Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290114710565AbutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
08800070203415ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203422ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203439ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203446ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228951ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228968ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228975ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228982ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228999ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203354ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26