(191 days)
No
The document describes the use of CAD/CAM technology for manufacturing, which is a standard digital design and fabrication process and does not inherently involve AI or ML. There are no mentions of AI, ML, or related concepts like training/test sets or performance metrics typically associated with AI/ML algorithms.
Yes
The device is described as a "metallic dental restorative device" intended for "restoring chewing function" in partially or fully edentulous patients. This directly addresses a health-related function.
No
Explanation: The device is described as a "metallic dental restorative device" intended for "restoring chewing function" by attaching to dental abutments. Its purpose is mechanical restoration, not diagnosis of a condition.
No
The device description explicitly states it is a "metallic dental restorative device" and is "manufactured in biocompatible Titanium alloy," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to restore chewing function in partially or fully edentulous patients by providing a dental restorative device that attaches to dental abutments. This is a mechanical function within the body.
- Device Description: The device is described as a metallic dental restorative device designed for attachment to dental abutments. It is manufactured from biocompatible Titanium alloy.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or determine the state of a disease or condition based on in vitro examination of specimens derived from the human body.
IVD devices are specifically designed to perform tests on samples like blood, urine, or tissue to provide information for diagnosis, monitoring, or screening. This device is a physical structure used for mechanical restoration within the mouth.
N/A
Intended Use / Indications for Use
The Osteon Precision Milled Suprastructure is indicated for attachments in the treatment of partially orfully edentulous for the purpose of restoring chewing function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.
The Osteon Milled Suprastructure is indicated for compatibility with the following abutment systems:
- Nobel Biocare Multi Unit Abutment Plus, 4.8mm, max 30°
- Nobel Biocare Xeal Abutments, 4.8mm, max 30°
- Nobel Biocare Multi Unit Abutment, 4.8mm, max 30°
- MIS Multi-unit Abutments, 4.8mm
- C1 Conical Connection Implant System, max 30°
- V3 Conical Connection Implant System, max 30°
- Internal Hex Implant System, max 30°
- Conical Connection, max 30°
- Southern Compact Conical Abutments, 4.8mm
- MAX Implant System, 0°
- Provata Implant System, max 30°
- Deep Conical (DC) Implants, 0°
- Piccolo Implants, 0°
- External Hex Implants, max 30°
- Astra Tech Implant System® Multi Base Abutment EV, 4.8mm, max 30°
- Keystone Multi Unit Abutment, 4.8mm, 0°
- Neodent GM Mini Conical Abutment, 4.8mm, max 30°
- Implant Direct GPS® Angled Abutment, 5.0mm, max 30°
- Dentium SuperLine® Abutments, 4.5-5.5mm, max 30°
- Zimmer Angled Tapered Abutments, 4.5mm, max 30°
- Paltop Multi Unit Abutment, 5.0mm, max 17°
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Osteon Precision Milled Suprastructures (also referred as superstructures) are metallic dental restorative device that is intended for attaching by screw retention to dental abutments to aid in the treatment of partial and totally edentulous patients for the purpose of restoring their chewing function. These suprastructures attach to previously-cleared original equipment manufacturers (OEM) dental abutments using the (OEM) prosthetic screws. The abutmentborne subject devices are indicated for placement only on OEM implant/abutment constructs placed according to the labeling of the previously-cleared systems, and not to exceed the maximum angulation allowed for each OEM implant/abutment construct as identified in the Indications for Use Statement of the subject system.
The Osteon Precision Milled Suprastructure is designed for an individual patient from scans of the patient's impression. The suprastructure is manufactured in biocompatible Titanium alloy with the aid of Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technology. All CAD/CAM fabrication is performed by Osteon Medical, within our premises.
Osteon Precision Milled Suprastructures facilitate the attachment of both removable and fixed dental prosthesis and hence categorized as type A and type B. The design specifications are listed in the table below.
-Type A: Intended to act as a supporting structure to facilitate the attachment of ● removable dental prosthesis and include: Primary Bar and Nexus Removable Bar.
-Type B: Intended to act as a supporting structure to facilitate the attachment of fixed dental prosthesis and include: Melbourne Bar and Nexus Fixed Bar
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Jaws (partially or fully edentulous)
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests Performed:
- Dimensional Analysis: Provided to demonstrate compatibility with identified OEM constructs.
- Fatigue Testing: Not performed because the devices are abutment-borne and not intended to compensate for angulation exceeding the maximum angulation of OEM angled abutments.
- Biocompatibility: ISO 10993-5 Cytotoxicity testing was performed. The patient contacting material (Titanium (Ti-6A1-4V) alloy) conforms to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI Alloy for Surgical Implant Application.
- Sterilization: Validation was conducted according to ISO 17665-1:2006 and ISO 17665-2 for moist heat sterilization. A validated pre-vacuum steam sterilization cycle is recommended for end users.
Clinical Tests Performed:
It was stated that clinical study was not necessary to support substantial equivalence due to the indication for use being the same as predicate and reference devices, dimensions being typical for dental restorative devices, and production process not employing novel technologies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ISUS Implant Suprastructures (K122424)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Panthera Dental Milled Bars (K173466), Multi-unit Abutment Plus, Nobel Biocare AB (K161416), TiUltra Implants and Xeal Abutments, Nobel Biocare AB (K202344), MIS C1 Narrow Platform Conical Connection Implant System and MIS C1 Wide Platform Conical Connection Abutments, MIS Implants Technologies Ltd. (K172505), MIS V3 Conical Connection Dental Implants Technologies Ltd. (K163349), Conical Connection Implants, MIS Implants Technologies Ltd. (K112162), MIS Internal Hex Dental Implant System, MIS Implants Technologies Ltd. (K180282), Southern Implants MAX Implant System, Southern Implants (Pty) Ltd (K191054), Provata Implant System, Paltop Advanced Dental Solution System K180465), Deep Conical (DC) Implants and Accessories, Southern Implants (Pty) Ltd (K163060), Piccolo Implants and Accessories, Southern Implants (Pty) Ltd (K173706), External Hex Implants, Southern Implants (Pty) Ltd (K163634), Multibase Abutments EV and ATLANTIS Suprastructures, Dentsply Sirona (K163350), PrimaConnex Internal Connection Implant System, Lifecore Biomedical, Inc. (K051614), Neodent Implant System - GM Line, JJGC Industria e Comercio de Materiais Dentarios SA (K163194), GPS® Angled Abutment, Implant Direct Sybron Manufacturing, LLC (K153509), Dentium Implantium® and SuperLine® Abutments, Dentium Company Limited (K141457), Angled Tapered Abutment, Zimmer Dental, Inc. (K111853), Paltop Advanced Dental Solution System, Paltop Advanced Dental Solutions Ltd. (K112795)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Implant Solutions PTY LTD (Osteon Medical) % Melissa Burbage Senior Regulatory Specialist PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K212676
Trade/Device Name: Osteon Precision Milled Suprastructure Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: January 28, 2022 Received: January 31, 2022
Dear Melissa Burbage:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212676
Device Name
Osteon Precision Milled Suprastructure
Indications for Use (Describe)
The Osteon Precision Milled Suprastructure is indicated for attachments in the treatment of partially orfully edentulous for the purpose of restoring chewing function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.
The Osteon Milled Suprastructure is indicated for compatibility with the following abutment systems:
- · Nobel Biocare Multi Unit Abutment Plus, 4.8mm, max 30°
- · Nobel Biocare Xeal Abutments, 4.8mm, max 30°
- · Nobel Biocare Multi Unit Abutment, 4.8mm, max 30°
- MIS Multi-unit Abutments, 4.8mm
- · C1 Conical Connection Implant System, max 30°
- · V3 Conical Connection Implant System, max 30°
- · Internal Hex Implant System, max 30°
- · Conical Connection, max 30°
- Southern Compact Conical Abutments, 4.8mm
- · MAX Implant System, 0°
- · Provata Implant System, max 30°
- · Deep Conical (DC) Implants, 0°
- · Piccolo Implants, 0°
- · External Hex Implants, max 30°
- · Astra Tech Implant System® Multi Base Abutment EV, 4.8mm, max 30°
- Keystone Multi Unit Abutment, 4.8mm, 0°
- · Neodent GM Mini Conical Abutment, 4.8mm, max 30°
- · Implant Direct GPS® Angled Abutment, 5.0mm, max 30°
- · Dentium SuperLine® Abutments, 4.5-5.5mm, max 30°
- · Zimmer Angled Tapered Abutments, 4.5mm, max 30°
- · Paltop Multi Unit Abutment, 5.0mm, max 17°
Type of Use (Select one or both, as applicable)
� Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the Osteon Medical logo. The logo consists of the word "Osteon" in a dark gray sans-serif font, with the word "medical" in a smaller font size underneath. To the right of the text is a blue circle containing a white abstract design that resembles two overlapping triangles.
510(k) SUMMARY
The assigned 510(k) number is: K212676
1. Submitter's Identification:
Manufacturer: Implant Solutions PTY LTD (trading as Osteon Medical) Address: 759-767 Springvale Road Mulgrave, Victoria, 3170 Australia
Contact: Ms. Andrea Del Ciotto Title: Head of Regulatory Compliance Phone Number: +61 408 583 222 Email: andrea@osteonmedical.com
Date Summary Prepared: March 3, 2022
Official Correspondent: Melissa Burbage or Floyd G. Larson PaxMed International. LLC Phone Number: (858) 792-1235 Email: mburbage@paxmed.com or flarson(@paxmed.com
2. Name of the Device:
Device Name(s): Osteon Precision Milled Suprastructure
Common Name: Overdenture Bar Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: Class II Product Code: NHA
3. Information for the 510(k) Cleared Device (Predicate Device):
Primary Predicate: ISUS Implant Suprastructures (K122424)
Reference Device: Panthera Dental Milled Bars (K173466)
Reference Devices for OEM Compatibilities Multi-unit Abutment Plus, Nobel Biocare AB (K161416) TiUltra Implants and Xeal Abutments, Nobel Biocare AB (K202344) MIS C1 Narrow Platform Conical Connection Implant System and MIS C1 Wide Platform Conical Connection Abutments, MIS Implants Technologies Ltd. (K172505) MIS V3 Conical Connection Dental Implants Technologies Ltd. (K163349) Conical Connection Implants, MIS Implants Technologies Ltd. (K112162) MIS Internal Hex Dental Implant System, MIS Implants Technologies Ltd. (K180282) Southern Implants MAX Implant System, Southern Implants (Pty) Ltd (K191054) Provata Implant System, Paltop Advanced Dental Solution System K180465) Deep Conical (DC) Implants and Accessories, Southern Implants (Pty) Ltd (K163060) Piccolo Implants and Accessories, Southern Implants (Pty) Ltd (K173706)
4
External Hex Implants, Southern Implants (Pty) Ltd (K163634) Multibase Abutments EV and ATLANTIS Suprastructures, Dentsply Sirona (K163350) PrimaConnex Internal Connection Implant System, Lifecore Biomedical, Inc. (K051614) Neodent Implant System - GM Line, JJGC Industria e Comercio de Materiais Dentarios SA (K163194) GPS® Angled Abutment, Implant Direct Sybron Manufacturing, LLC (K153509)
Dentium Implantium® and SuperLine® Abutments, Dentium Company Limited (K141457) Angled Tapered Abutment, Zimmer Dental, Inc. (K111853) Paltop Advanced Dental Solution System, Paltop Advanced Dental Solutions Ltd. (K112795)
4. Device Description:
The Osteon Precision Milled Suprastructures (also referred as superstructures) are metallic dental restorative device that is intended for attaching by screw retention to dental abutments to aid in the treatment of partial and totally edentulous patients for the purpose of restoring their chewing function. These suprastructures attach to previously-cleared original equipment manufacturers (OEM) dental abutments using the (OEM) prosthetic screws. The abutmentborne subject devices are indicated for placement only on OEM implant/abutment constructs placed according to the labeling of the previously-cleared systems, and not to exceed the maximum angulation allowed for each OEM implant/abutment construct as identified in the Indications for Use Statement of the subject system.
The Osteon Precision Milled Suprastructure is designed for an individual patient from scans of the patient's impression. The suprastructure is manufactured in biocompatible Titanium alloy with the aid of Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technology. All CAD/CAM fabrication is performed by Osteon Medical, within our premises.
Osteon Precision Milled Suprastructures facilitate the attachment of both removable and fixed dental prosthesis and hence categorized as type A and type B. The design specifications are listed in the table below.
- Type A: Intended to act as a supporting structure to facilitate the attachment of ● removable dental prosthesis and include: Primary Bar and Nexus Removable Bar.
- . Type B: Intended to act as a supporting structure to facilitate the attachment of fixed dental prosthesis and include: Melbourne Bar and Nexus Fixed Bar
| Description | Type A (facilitates
Prosthesis) | Removable | Type B (facilitates
Prosthesis) | Fixed |
|-----------------------------------------------|------------------------------------|-----------|------------------------------------|---------|
| | Minimum | Maximum | Minimum | Maximum |
| Total Cylinders | 2 | 10 | 2 | 10 |
| Suprastructure Span Between
Cylinders (mm) | 1 | 30 | 1 | 30 |
| Suprastructure Height (mm) | 3 | 12 | 3 | 22 |
| Suprastructure Width (mm) | 3.4 | 12 | 3.4 | 12 |
| Distal Cantilever Section (mm) | 0 | 15 | 0 | 15 |
| Cylinder Height (mm) | 0 | 4.6 | 0 | 4.6 |
| Cylinder Diameter (mm) | 4.5 | 8 | 4.5 | 8 |
The table below presents the design specifications for two categories of suprastructures:
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Image /page/5/Picture/0 description: The image shows the logo for Osteon Medical. The logo consists of the word "Osteon" in gray, with the word "medical" in a smaller font size underneath. To the right of the text is a blue circle containing a white abstract design that resembles two overlapping triangles.
Indications for Use: 5.
The Osteon Precision Milled Suprastructure is indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.
The Osteon Milled Suprastructure is indicated for compatibility with the following abutment systems:
- Nobel Biocare Multi Unit Abutment Plus, 4.8mm, max 30°
- . Nobel Biocare Xeal Abutments, 4.8mm, max 30°
- Nobel Biocare Multi Unit Abutment, 4.8mm, max 30°
- . MIS Multi-unit Abutments, 4.8mm
- O C1 Conical Connection Implant System, max 30°
- V3 Conical Connection Implant System, max 30° O
- Internal Hex Implant System, max 30° O
- O Conical Connection, max 30°
- Southern Compact Conical Abutments, 4.8mm .
- MAX Implant System, 0° O
- O Provata Implant System, max 30°
- Deep Conical (DC) Implants, 0° O
- Piccolo Implants, 0° O
- External Hex Implants, max 30° O
- Astra Tech Implant System® Multi Base Abutment EV, 4.8mm, max 30°
- . Keystone Multi Unit Abutment, 4.8mm, 0°
- Neodent GM Mini Conical Abutment, 4.8mm, max 30°
- lmplant Direct GPS® Angled Abutment, 5.0mm, max 30° ●
- Dentium SuperLine® Abutments, 4.5-5.5mm, max 30°
- . Zimmer Angled Tapered Abutments, 4.5mm, max 30°
- . Paltop Multi Unit Abutment, 5.0mm, max 17°
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Image /page/6/Picture/0 description: The image shows the logo for Osteon Medical. The logo consists of the word "Osteon" in a dark gray sans-serif font, with the word "medical" in a smaller font below it. To the right of the text is a blue circle with a white abstract shape inside, resembling two triangles pointing in opposite directions.
| | 1. Subject Device | 2. Predicate Device | 2. Reference Device | Similar or Different
1 vs 2 |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Feature | Osteon Precision Milled Suprastructure | ISUS Implant Suprastructure | Panthera Dental Milled Bars
Reference Device K173466 | |
| | | Primary Predicate K122424 | | |
| Regulation
description | Endosseous dental implant abutment | Endosseous dental implant abutment | Endosseous dental implant abutment | Similar ✔ |
| Indications for Use | The Osteon Precision Milled Suprastructure is indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments. The Osteon Precision Milled Suprastructures are indicated for compatibility with the following abutment systems:
• Nobel Biocare Multi Unit Abutment Plus, 4.8mm, max 30°
• Nobel Biocare Xeal Abutments, 4.8mm, max 30°
• Nobel Biocare Multi Unit Abutment, 4.8mm, max 30°
• MIS Multi-unit Abutments, 4.8mm
o C1 Conical Connection Implant System, max 30°
o V3 Conical Connection Implant System, max 30°
o Internal Hex Implant System, max 30°
o Conical Connection, max 30°
• Southern Compact Conical Abutments, 4.8mm
o MAX Implant System, 0°
o Provata Implant System, max 30°
o Deep Conical (DC) Implants, 0°
o Piccolo Implants, 0°
o External Hex Implants, max 30°
• Astra Tech Implant System® Multi Base Abutment EV, 4.8mm, max 30°
• Keystone Multi Unit Abutment, 4.8mm, 0°
• Neodent GM Mini Conical Abutment, 4.8mm, max 30°
• Implant Direct GPS® Angled Abutment, 5.0mm, max 30° | The ISUS Implant Suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The ISUS Implant Suprastructures are intended for attachment to a minimum of two (2) implants. The ISUS Implant suprastructures are indicated for compatibility with the following implant and abutment systems:
Implants:
• Nobel Biocare Replace Select: NP (3.5mm), RP (4.3mm), WP (5.0mm), and Replace Select 6.0mm
• Nobel Biocare Active Internal: NP (3.5mm), RP (4.3mm, 5.0mm)
• Zimmer Screw Vent: D3.5, D4.5, D5.7
• Straumann: NN (3.5mm), RN (4.8mm), WN (6.0mm)
• Straumann Bone Level: NC (3.3mm), RC (4.1 mm, 4.8mm)
• 3I Internal Connection: D3.4, D4.1, D5, D6
• Friadent XIVE S: D3, D3.4, D3.8, D4.5, D5.5
Abutments:
• ASTRA TECH 20° and 45° UniAbutment
• ASTRA TECH UniAbutment EV: 3.6
• ANKYLOS Balance Base Abutment D5.5 and Narrow Abutment D4.2
• Nobel Biocare Multi -Unit Abutment RP: 4.0 mm
• Zimmer Tapered Abutment: 4.5mm
• Straumann RN (4.8mm), WN (6.5 mm)
• Straumann Bone Level: Multi-Base Abutment D3.5, D4.5 | As an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained.
Compatibility with the Zimmer Tapered Screw-Vent System for sizes 3.5 and 4.5. | Similar ✔
(1 – See below) |
| Feature | 1. Subject Device
Osteon Precision Milled Suprastructure | 2. Predicate Device
ISUS Implant Suprastructure
Primary Predicate K122424 | 2. Reference Device
Panthera Dental Milled Bars
Reference Device K173466 | Similar or Different
1 vs 2 |
| | • Dentium SuperLine® Abutments, 4.5-5.5mm,
max 30°
• Zimmer Angled Tapered Abutments, 4.5mm,
max 30°
• Paltop Multi Unit Abutment, 5.0mm, max 17° | • Straumann Bone Level Angled
Abutment:4.0 mm
• 3I Low Profile Abutment
• Friadent XiVE MP D3.8, D4.5, D5.5
• Friadent XiVE TG 03.8, 04.5, 05.5 | | |
| Device Material | Titanium alloy Ti-6Al- 4V | Commercially-Pure (CP) Titanium and Cobalt-
Chromium alloy | Titanium alloy Ti-6Al- 4V | Similar ✔
(2 - See below) |
| Design/ Technology | Single milling blocks | Single milling blocks | CAD/CAM milling from single milling blanks. | Similar ✔ |
| Fixation Method | CAD/CAM milling from single milling blanks. | CAD/CAM milling from single milling blanks | Implant-borne | Similar ✔ |
| Design/
Construction | Abutment-borne | Implant-borne or abutment-borne | Patient specific/ machined | Similar ✔ |
| Sterility | Patient specific/ machined | Patient specific/ machined | Supplied Nonsterile | Similar ✔ |
| Target population | Supplied Nonsterile | Supplied Nonsterile | Adult patients | Similar ✔ |
| Prescription/ OTC | Adult patients | Adult patients | Prescription only | Similar ✔ |
| Recommended
Cleaning and
Maintenance | Prescription only | Prescription only | Proper oral hygiene | Similar ✔ |
| Design
specifications | Proper oral hygiene | Proper oral hygiene | See tables below | Similar ✔
(3 - See below) |
| | See tables below | See tables below | | |
6. Comparison to the 510(k) Cleared Devices (Predicate and Reference Devices):
510k Summary for Osteon Dental Milled Suprastructure
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Image /page/7/Picture/0 description: The image contains the logo for Osteon Medical. The logo consists of the word "Osteon" in a bold, sans-serif font, with the word "medical" in a smaller font underneath. To the right of the text is a blue circle containing a white, stylized shape that resembles two overlapping triangles or arrowheads. The overall design is clean and modern.
(1) Indications for User. Subject, predicated for attachment to dental implants or abutments in the treatment of partially of filly edentulous jaws for the purpose of resoring chevice is similar to primary predicate (KI2424) and listed all compatible abutments and implants systems, however reference device | KT3466 is compatible to only one impribilities have been addressed by the identification of the reference devices (identified in Reference Devices for OEM Compatibilities) as well as by the reverse-engineering/dimensional analysis provided.
(2) Device Material: Material of subject device is same as reference device(K173466).
(3) Design specifications: Same as reference device (K173466). Relevant information not visible for primary predicate (K22424). See following two tables below for data.
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Image /page/8/Picture/0 description: The image shows the logo for Osteon Medical. The logo consists of the word "Osteon" in a dark gray sans-serif font, with the word "medical" in a smaller font below it. To the right of the text is a blue circle containing two white arrow-like shapes pointing towards each other.
| Design Parameter | 1. Subject Device
Osteon Precision Milled
Suprastructure | | 2. Predicate Device
ISUS Implant
Suprastructure
Primary Predicate K122424 | | 2. Reference Device
Panthera Dental Milled
Bars
Reference DeviceK173466 | | Similar or Different
1 vs 2 |
|------------------------------------------------|----------------------------------------------------------------|-------|------------------------------------------------------------------------------------|---------------|----------------------------------------------------------------------------------|------|--------------------------------|
| | Min | Max | Min | Max | Min | Max | |
| Total Cylinders | 2 | 10 | 2 | Not available | 2 | 10 | Similar ✔
(4 - See below) |
| Suprastructure/Bar
between Cylinders | 1mm | 30mm | Not available | Not available | 0mm | 30mm | Similar ✔
(5 - See below) |
| Suprastructure/Bar Height | 3mm | 12mm | Not available | Not available | 2.5mm | 8mm | Similar ✔
(6 - See below) |
| Suprastructure/Bar Width | 3.4mm | 12mm | Not available | Not available | 1.5mm | 12mm | Similar ✔
(5 - See below) |
| Distal Cantilever Section/ Distal
Extension | 0mm | 15mm | Not available | Not available | 0mm | 30mm | Similar ✔
(5 - See below) |
| Cylinder Height | 0mm | 4.6mm | Not available | Not available | 0mm | 10mm | Similar ✔
(5 - See below) |
| Cylinder Diameter | 4.5mm | 8mm | Not available | Not available | 3mm | 8mm | Similar ✔
(5 - See below) |
Table 2: Comparison chart of design parameters for Type A Suprastructure (removable prosthesis) with primary and reference devices
(4) Same as reference device (K17346), Minimum no of cylinders (abutments) the device supports is same as primary predicate (K1224-24).
Osteon device dimension for reference device (K173466). Relevant information not visible for primary predicate (K12424). This will have no impact on (2) safety and efficacy.
Osteon devices can support wide suprastructure/bar her eference device/K173466). Relevant information not visble for primary predicate (K12242). This will (6) have no impact on safety and efficacy as Osteon devices dimension allows more material making it more stable.
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Image /page/9/Picture/0 description: The image shows the logo for Osteon Medical. The logo consists of the word "Osteon" in a bold, sans-serif font, with the word "medical" in a smaller font below it. To the right of the text is a blue circle with two white triangles inside, arranged in a way that suggests forward movement or progress. The overall design is clean and modern, conveying a sense of professionalism and innovation.
| Design Parameter | 1. Subject Device
Osteon Precision Milled
Suprastructure | | 2. Predicate Device
ISUS Implant
Suprastructure
Primary Predicate K122424 | | 2. Reference Device
Panthera Dental Milled
Bars
Reference DeviceK173466 | | Similar or Different
1 vs 2 |
|------------------------------------------------|----------------------------------------------------------------|-------|------------------------------------------------------------------------------------|---------------|----------------------------------------------------------------------------------|---------------|--------------------------------------------------------------------------------|
| | Min | Max | Min | Max | Min | Max | |
| Total cylinders | 2 | 10 | 2 | Not available | 2 | 10 | Similar ✔
(7 - See below) |
| Suprastructure/Bar
between Cylinders | Span 1mm | 30mm | Not available | Not available | 0mm | 30mm | Similar ✔
(8 - See below) |
| Suprastructure/Bar Height | 3mm | 22mm | Not available | Not available | 3.5mm | 22mm | Similar ✔
(9 - See below) |
| Suprastructure/Bar Width | 3.4mm | 12mm | Not available | Not available | 2.5mm | 10mm | Similar ✔
(10 - See below). |
| Distal Cantilever Section/ Distal
Extension | 0mm | 15mm | Not available | Not available | 0mm | 30mm | Similar ✔
(8 - See below) |
| Cylinder Height | 0mm | 4.6mm | Not available | Not available | Not available | Not available | Design parameter not specified for
primary predicate and reference devices. |
| Cylinder Diameter | 4.5mm | 8mm | Not available | Not available | Not available | Not available | Design parameter not specified for
primary predicate and reference devices. |
Table 3: Comparison chart of design parameters for Type B Suprastructure (Fixed prosthesis) with primary predicate and reference devices
Same as reference device (K173466). Minimum no of cylinters) the device can support is same as primary predicate (K122424). (7)
(8) Osteon device dimension for elemente device(473466). Relevant information not visible for primary predicate (K22424). This will have no impact on safety and efficacy.
(9) Osteon devices allow wider suprastructure/bar height than reference device (K173466). This will have no impact on safety and efficacy.
(0) Osteon device can have maximum suprastiutures with (173466). Relevant information not visible for primary predicate (K2224). This will have no impact on safety and efficacy as Osteon devices dimension allows more material making it more stable.
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Image /page/10/Picture/0 description: The image contains the logo for Osteon Medical. The logo consists of the word "Osteon" in a dark gray sans-serif font, with the word "medical" in a smaller font below it. To the right of the text is a blue circle containing a white abstract shape that resembles two overlapping triangles.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
The following section contains discussion of the non-clinical tests performed for the determination of substantial equivalence to predicate and reference devices. The non-clinical testing includes assessment of the physical properties of the bars and its ability to achieve its intended use. The bars meet the same specifications as set for the primary and reference devices.
Dimensional Analysis
Dimensional analysis (reverse-engineering) was provided to demonstrate compatibility with the identified OEM constructs.
Fatigue Testing
Fatigue testing was not performed since the subject devices are abutment-borne and are not intended to compensate for angulation in excess of the maximum angulation of OEM angled abutments in each reference device clearance, as outlined in the Indications for Use Statement.
Biocompatibility
Our patient contacting material is Titanium (Ti-6A1-4V) alloy and it is the same material as that of the Panthera predicate K173466. ISO 10993-5 Cytotoxicity testing was performed on the subject device. The patient contacting material conforms to the ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI Alloy for Surgical Implant Application.
Sterilization
Osteon Precision Milled Suprastructure are provided non-sterilization is to be conducted by end user prior to first use. Sterilization validation according to ISO 17665-1:2006 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices and ISO 17665-2 Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1 was conducted for the Osteon Precision Milled Suprastructure. The validated pre-vacuum steam sterilization cycle is recommended to the end users and specified in the Instructions for Use.
Discussion of Clinical Tests Performed:
The indication for use for Osteon Precision Milled Suprastructure is same as that identified in the predicate and reference devices. The dimensions of Osteon Milled Suprastructure are typical for dental restorative devices and same as other previously cleared devices under 510(k). In addition, the production process does not employ any novel technologies that is different from legally marketed dental restorative devices. Hence, Osteon Medical found it was not necessary to conduct human clinical study to support substantial equivalence.
Conclusion
The proposed device, Osteon Precision Milled Suprastructure, is similar to the predicate and reference devices based on the following - it has same intended use, indications for use, aimed for same user population, made of similar biocompatible materials, has equivalent technological characteristics and as such is improbable to increase or add new risks in the final device. The differences in subject, predicate, and reference devices were addressed with the non-clinical bench testing summarized above, as well as appropriate labeling mitigations to ensure adequate use of the device by the end-users. The data included in this submission demonstrate substantial equivalence to the predicate and reference devices listed above.