FDA.reportPublic FDA data

Implant-One

Primary DI
D762HDT7050010
Brand
Implant-One
Company
Implant Logistics, Inc.
Model
HDT-7050-01
Device description
".050"" Tapered Hex Driver, Long, Hand Piece Style"
Published
2022-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
D762HDT7050010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-844-383-8001CustomerService@implantlogistics.com

Regulatory Flags#

DUNS number
079280537
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D762IR33508000Implant-OneIR3-3508-002020-08-20
D762AWP0305000Implant-OneAWP-0305-002020-09-02
D762AWP0310000Implant-OneAWP-0310-002020-09-02
D762AWP0320000Implant-OneAWP-0320-002020-09-02
D762AWP0330000Implant-OneAWP-0330-002020-09-02
D762AWP0340000Implant-OneAWP-0340-002020-09-02
D762AWP0350000Implant-OneAWP-0350-002020-09-02
D762AWP0405000Implant-OneAWP-0405-002020-09-02
D762AWP0410000Implant-OneAWP-0410-002020-09-02
D762AWP0420000Implant-OneAWP-0420-002020-09-02
D762AWP0430000Implant-OneAWP-0430-002020-09-02
D762AWP0440000Implant-OneAWP-0440-002020-09-02
D762AWP0450000Implant-OneAWP-0450-002020-09-02
D762AWP0505000Implant-OneAWP-0505-002020-09-02
D762AWP0510000Implant-OneAWP-0510-002020-09-02
D762AWP0520000Implant-OneAWP-0520-002020-09-02
D762AWP0530000Implant-OneAWP-0530-002020-09-02
D762AWP0540000Implant-OneAWP-0540-002020-09-02
D762AWP0550000Implant-OneAWP-0550-002020-09-02
D762CSR0300000Implant-OneCSR-0300-002020-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435673516664DYNAMIC ABUTMENT SOLUTIONSTALLADIUM ESPAÑA SLNDP2026-07-03
00842092187722PreatPreat CorporationNDP2026-06-08
08056591028154JDentalCare Dental InstrumentsJ DENTAL CARE SRLNDP2026-06-08
00840481133756LOCATORZest Anchors, LLCNDP2026-06-05
07630031778086NAInstitut Straumann AGNDP2026-06-03
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07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
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07630031778413NAInstitut Straumann AGNDP2026-06-03