FDA.reportPublic FDA data

INTERNAL HEX

Primary DI
00614950026883
Brand
INTERNAL HEX
Company
ACE SURGICAL SUPPLY CO., INC.
Model
20450001
Catalog number
20450001
Device description
INTERNAL HEX MULTI-UNIT ABUTMENT 4.5 PLATFORM X1MM H. STRAIGHT
Published
2023-04-06
Public version status
New
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
NHAAbutment, implant, dental, endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614950026883PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614950026883006149500268836149500268830614950026883

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis/implant abutment screwA device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
042763706
Device count
1
Lot or batch
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
00842092170199PreatPreat CorporationNHA2026-06-09
00842092174999PreatPreat CorporationNHA2026-06-09
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04260516873079SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873086SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873093SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873109SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
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04260516873338SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
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04260516873352SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
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04260516873628SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874465SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
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04260516874731SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874748SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874755SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874809SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874816SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
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