Separable Fastener Assembly 10PK - Drill Kit Included, Paltop (IHex)

Primary DI
D990KDIHSFA10PKDK0
Brand
Separable Fastener Assembly 10PK - Drill Kit Included, Paltop (IHex)
Company
SMART DENTURE CONVERSIONS, LLC
Model
KDIH-SFA10PKDK
Published
2022-12-26
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
EJXAnchor, Preformed
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJXAnchor, PreformedDental1
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D990KDIHSFA10PKDK0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Steel dental bur, reusableA rotary cutting device made from high-grade carbon steel with the working end typically formed with cutting planes, e.g., spiralled flutes, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
855-550-0707Contact@SmartDentureConversions.com

Regulatory Flags#

DUNS number
010613514
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D990SADCK1PK0Single Arch Dam Conversion Kit 1PKSADCK1PK2025-06-30
D990AD0Access Drill 1PKAD2022-12-26
D990BHHDPS10PK0Prosthetic Screw 10PK, BioHorizonsBHHD-PS10PK2022-12-26
D990BHHDPSK0Premium Starter Kit, BioHorizonsBHHD-PSK2022-12-26
D990BHHDRK0Recharge Kit, BioHorizonsBHHD-RK2022-12-26
D990BHHDSFA10PKDK0Separable Fastener Assembly 10PK w Drill Kit, BioHorizonsBHHD-SFA10PKDK2022-12-26
D990BHHDSK0Starter Kit, BioHorizonsBHHD-SK2022-12-26
D990CM10PK0Coating Mandrel 10PKCM10PK2022-12-26
D990CM6PK0Coating Mandrel 6PKCM6PK2022-12-26
D990COD0Clean Out Drill 1PKCOD2022-12-26
D990DK0Drill Kit 1PKDK2022-12-26
D990KDIHCM10PK0Coating Mandrel 10 Pack, Paltop (IHEX)KDIH-CM10PK2022-12-26
D990KDIHCM6PK0Coating Mandrel 6PK, Paltop (IHex)KDIH-CM6PK2022-12-26
D990KDIHLA10PK0Lab Analog 10PK, Paltop (IHex)KDIH-LA10PK2022-12-26
D990KDIHLTD0Torque Driver 1PK, Paltop (IHex)KDIH-LTD2022-12-26
D990KDIHPS10PK0Prosthetic Screw 10PK, Paltop (IHex)KDIH-PS10PK2022-12-26
D990KDIHPSK0Premium Starter Kit, Paltop (IHex)KDIH-PSK2022-12-26
D990KDIHRK0Recharge Kit, Paltop (IHex)KDIH-RK2022-12-26
D990KDIHSK0Starter Kit, Paltop (IHex)KDIH-SK2022-12-26
D990KDIHSTB10PK0Standard TiBase 10PK, Paltop (IHex)KDIH-STB10PK2022-12-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092187722PreatPreat CorporationNDP2026-06-08
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00840481133756LOCATORZest Anchors, LLCNDP2026-06-05
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