FDA.reportPublic FDA data

FD500-neo

Primary DI
07640166763758
Brand
FD500-neo
Company
Z-Systems AG
Model
FD500-neo
Catalog number
FD500-neo
Device description
Form Drill for Zm5(t)-neo Ø5.0 mm
Published
2026-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640166763758PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640166763758076401667637587640166763758

GMDN Terms#

Term, Definition table
TermDefinition
Fixture/appliance dental drill bit, reusableA shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+41623886969support@zsystems.com

Regulatory Flags#

DUNS number
483189556
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640166763567Z5m(t)-neoZ5m(t)-neo-4008Z5m(t)-neo-40082026-05-17
07640166763574Z5m(t)-neoZ5m(t)-neo-4010Z5m(t)-neo-40102026-05-17
07640166763581Z5m(t)-neoZ5m(t)-neo-4012Z5m(t)-neo-40122026-05-17
07640166763703Z5m(t)-neoZ5m(t)-neo-5008Z5m(t)-neo-50082026-05-17
07640166763710Z5m(t)-neoZ5m(t)-neo-5010Z5m(t)-neo-50102026-05-17
07640166763727Z5m(t)-neoZ5m(t)-neo-5012Z5m(t)-neo-50122026-05-17
07640166763741FD400-neoFD400-neoFD400-neo2026-05-17
07640166765905TD230-1TD230-1TD230-12026-05-17
07640166765936TD285-1TD285-1TD285-12026-05-17
07640166769521Z5m(t)-neo InsertZ5m(t)-neo InsertZ5m(t)-neo Insert2026-05-17
07640166769651Z5m(t)-neo Tray FullZ5m(t)-neo Tray FullZ5m(t)-neo Tray Full2026-05-17
07640166769668DP230-1DP230-1DP230-12026-05-17
07640166769675DP285-1DP285-1DP285-12026-05-17
07640166760405Z5cZ5c-40-08Z5c-40-082015-08-25
07640166760412Z5cZ5c-40-10Z5c-40-102015-08-25
07640166760429Z5cZ5c-40-12Z5c-40-122015-08-25
07640166760436Z5cZ5c-50-08Z5c-50-082015-08-25
07640166760443Z5cZ5c-50-10Z5c-50-102015-08-25
07640166760450Z5cZ5c-50-12Z5c-50-122015-08-25
07640166769491Z5mZ5m-36-10Z5m-36-102015-08-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08059224151496OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
08059224151502OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
08059224151588OT EQUATORRHEIN 83 SRLNDP2026-08-27
08059224218205OT EQUATORRHEIN 83 SRLNDP2026-08-27
08059224218335OT EQUATORRHEIN 83 SRLNDP2026-08-27
08059224218700OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
08059224218717OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
08800131092064DenQ Sub Multi-unit Pick-up Impression copingDenQ Co.,Ltd.NDP2026-08-25
08800131098264DenQ Sub Multi-unit Lab AnalogDenQ Co.,Ltd.NDP2026-08-25
00840481138041LOCATOR Angled AbutmentZest Anchors, LLCNDP2026-08-21
00840481138058LOCATOR Angled AbutmentZest Anchors, LLCNDP2026-08-21
08800313235449Guide Anchor PinDENTIS CO. ,LTDNDP2026-08-19
08800313235456Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235463Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235470Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235487Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235494Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235500Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235517Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235524Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235531Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235548Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235555Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235562Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
04260516875448SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516875455SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516875462SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516875479SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516878197SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
07290108810639Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18