FDA.reportPublic FDA data

ACE

Primary DI
00614950002085
Brand
ACE
Company
ACE SURGICAL SUPPLY CO., INC.
Model
08305002
Catalog number
08305002
Device description
TEMP HEAL ABUT 5HD 6.5CW 4CH (TI6AL4VELI)
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K954513000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K954513000ACE SREW DENTLA IMPLANT SYSTEMAce Surgical Supply Co., Inc.1996-06-05DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614950002085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614950002085006149500020856149500020850614950002085

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, one-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) that protrudes through gingival tissues to support the prosthesis.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width6.5Millimeter

Sterilization Methods#

Method table
Method
Radiation Sterilization

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
Sterilization required before use
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
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
08800070230367ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070230374ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070230381ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070230398ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229125ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229132ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229149ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229156ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229163ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229170ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229187ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229194ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229200ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229217ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229231ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229248ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229255ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229262ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229279ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229286ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229309ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229316ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229323ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229330ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26