FDA.reportPublic FDA data

Infinity Internal Hex System

Primary DI
00614950004850
Brand
Infinity Internal Hex System
Company
ACE SURGICAL SUPPLY CO., INC.
Model
20585501
Catalog number
20585501
Device description
COVER SCREW FOR 4.5MM INTERNAL HEX IMPLANT STERILE 6AL 4V ELI
Published
2015-10-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102981000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102981000ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEMAce Surgical Supply Company, Inc.2010-12-20DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614950004850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614950004850006149500048506149500048500614950004850

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width4.5Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)588-3100ritaknight@acesurgical.com

Regulatory Flags#

DUNS number
042763706
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00614950025510ACE003293700329372019-10-24
00614950025558ACE080000208000022019-10-24
00614950025565ACE080000308000032019-10-24
00614950025572ACE080001108000112019-10-24
00614950013425ACE003105900310592019-10-16
00614950031207ACE484200248420022023-12-05
00614950031214ACE484200348420032023-12-05
00614950030149ACE20982511209825112023-12-05
00614950030927ACE45450201454502012023-12-05
00614950012831ACE90440018S90440018S2019-10-13
00614950012848ACE90440018ST90440018ST2019-10-13
00614950026272ACE90250018902500182019-10-13
00614950026289ACE90250023902500232019-10-13
00614950026296ACE90440018904400182019-10-13
00614950026302ACE90440023904400232019-10-13
00614950026319ACE90440023S90440023S2019-10-13
00614950026326ACE90440023ST90440023ST2019-10-13
00614950026333ACE90500018905000182019-10-13
00614950026340ACE90500018S90500018S2019-10-13
00614950026357ACE90500023905000232019-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800070229125ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229132ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229149ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229156ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229163ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229170ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229187ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229194ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229200ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229217ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229231ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229248ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229255ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229262ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229279ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229286ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229309ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229316ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229323ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229330ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070228951ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228968ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228975ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08809822767892AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767908AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767922AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767946AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767953AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12