FDA.reportPublic FDA data

Elos Prosthetic Screw

Primary DI
05712821010490
Brand
Elos Prosthetic Screw
Company
Elos Medtech Pinol A/S
Model
AS-HETM1610POS
Catalog number
AS-HETM1610POS
Device description
The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Published
2024-02-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231307000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231307000Elos Accurate Customized AbutmentElos Medtech Pinol A/S2023-12-21NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05712821010490PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05712821010490057128210104905712821010490

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
306155953
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05712821014696Elos Accurate Hybrid Base G EngagingHBE-ATE30-G1.0HBE-ATE30-G1.02026-10-06
05712821014702Elos Accurate Hybrid Base G EngagingHBE-ATE30-G2.0HBE-ATE30-G2.02026-10-06
05712821014719Elos Accurate Hybrid Base G EngagingHBE-ATE30-G3.0HBE-ATE30-G3.02026-10-06
05712821014726Elos Accurate Hybrid Base G EngagingHBE-ATE30-G4.0HBE-ATE30-G4.02026-10-06
05712821014733Elos Accurate Hybrid Base G EngagingHBE-ATE36-G1.0HBE-ATE36-G1.02026-10-06
05712821014740Elos Accurate Hybrid Base G EngagingHBE-ATE36-G2.0HBE-ATE36-G2.02026-10-06
05712821014757Elos Accurate Hybrid Base G EngagingHBE-ATE36-G3.0HBE-ATE36-G3.02026-10-06
05712821014764Elos Accurate Hybrid Base G EngagingHBE-ATE36-G4.0HBE-ATE36-G4.02026-10-06
05712821014771Elos Accurate Hybrid Base G EngagingHBE-ATE42-G1.0HBE-ATE42-G1.02026-10-06
05712821014788Elos Accurate Hybrid Base G EngagingHBE-ATE42-G2.0HBE-ATE42-G2.02026-10-06
05712821014795Elos Accurate Hybrid Base G EngagingHBE-ATE42-G3.0HBE-ATE42-G3.02026-10-06
05712821014801Elos Accurate Hybrid Base G EngagingHBE-ATE42-G4.0HBE-ATE42-G4.02026-10-06
05712821014818Elos Accurate Hybrid Base G EngagingHBE-ATE48-G1.0HBE-ATE48-G1.02026-10-06
05712821014825Elos Accurate Hybrid Base G EngagingHBE-ATE48-G2.0HBE-ATE48-G2.02026-10-06
05712821014832Elos Accurate Hybrid Base G EngagingHBE-ATE48-G3.0HBE-ATE48-G3.02026-10-06
05712821014849Elos Accurate Hybrid Base G EngagingHBE-ATE48-G4.0HBE-ATE48-G4.02026-10-06
05712821014856Elos Accurate Hybrid Base G EngagingHBE-ATE54-G1.0HBE-ATE54-G1.02026-10-06
05712821014863Elos Accurate Hybrid Base G EngagingHBE-ATE54-G2.0HBE-ATE54-G2.02026-10-06
05712821014870Elos Accurate Hybrid Base G EngagingHBE-ATE54-G3.0HBE-ATE54-G3.02026-10-06
05712821014887Elos Accurate Hybrid Base G EngagingHBE-ATE54-G4.0HBE-ATE54-G4.02026-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
088000968494068plant Implant System8dent Inc.NHA2026-10-20
088000968498338plant Implant System8dent Inc.NHA2026-10-20
088000968514618plant Implant System8dent Inc.NHA2026-10-20
088000968514788plant Implant System8dent Inc.NHA2026-10-20
088000968514858plant Implant System8dent Inc.NHA2026-10-20
088000968515778plant Implant System8dent Inc.NHA2026-10-20
088000968611568plant Implant System8dent Inc.NHA2026-10-20
088000968621608plant Implant System8dent Inc.NHA2026-10-20
088000968621778plant Implant System8dent Inc.NHA2026-10-20
088000968642878plant Implant System8dent Inc.NHA2026-10-20
088000968645778plant Implant System8dent Inc.NHA2026-10-20
088000968782398plant Implant System8dent Inc.NHA2026-10-20
10841307135883Legacy™ DIRECTarch™ 3.0 MUA Replacement ScrewIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135890Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 1.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135906Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 2.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135913Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 3.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135920Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 4.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135937Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 5.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135944Legacy™ DIRECTarch™ 3.0mmD Platform 17° MUA 1.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135951Legacy™ DIRECTarch™ 3.0mmD Platform 17° MUA 2.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135968Legacy™ DIRECTarch™ 3.0mmD Platform 30° MUA 1.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135975Legacy™ DIRECTarch™ 3.0mmD Platform 30° MUA 2.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135982Legacy™ DIRECTarch™ 3.5 MUA Replacement ScrewIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135999Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 1.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307136002Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 2.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307136019Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 3.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307136026Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 4.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307136033Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 5.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307136040Legacy™ DIRECTarch™ 3.5mmD Platform 17° MUA 1.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307136057Legacy™ DIRECTarch™ 3.5mmD Platform 17° MUA 2.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20