(79 days)
The Panthera Dental Milled Bar is indicated for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient for purpose of restoring chewing function. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained.
The Panthera Dental Milled Bars are indicated for compatibility with the Zimmer Tapered Screw-Vent System for sizes 3.5 and 4.5.
The Panthera Dental Milled Bar is a metallic dental restorative device which is intended for attaching by screw retention to dental implants to aid in the treatment of partial and totally edentulous patients for the purpose of restoring chewing function.
The Panthera Dental milled bars for which clearance is requested, are included in one of the following bar types, which have distinct design specifications.
The Type I bars are specific for removable overdenture and include:
- Panthera Dental Dolder Bar, Hader Bar, Milled Bar, REBourke Bar and Paris Bar.
The Type II bars are specific for fixed prostheses and include:
- Panthera Dental Wrap-around Bar, Montreal Bar, Montreal Bar with metallic lingual, Pin Lingual Bar and Pin Wrap-Around Bar.
The Panthera Dental Milled Bar is designed to match an individual patient. Panthera Dental designs the bar from a three-dimensional optical and/or digital scanner system that scans the casting of a patient's impression: the model cast is prepared beforehand by the dental professional using standard dental techniques. The designed bar is then machined using a computer-aided design/ computer-aided manufacturing software system (CAD/CAM). The bar is milled from titanium (Ti-6AI-4V grade 5). CAD/CAM fabrication is only performed by Panthera Dental, within our manufacturing control and not by the dental laboratory.
The Panthera Dental Milled Bar is packaged as non-sterile, and delivered to a dental laboratory for completion. Once received at the laboratory, the Panthera Dental Milled Bar is matched to a denture for final placement.
The Panthera Dental Milled Bar provides retention and support for a removable or fixed denture made of standard laboratory dental materials such as resin composite.
The provided text is a 510(k) summary for a medical device (Panthera Dental Milled Bars), which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving acceptance criteria for an AI/CADe device.
Therefore, this document does not contain the information required to answer your request about acceptance criteria and a study proving device performance for an AI/CADe device.
Here's why and what kind of information would be needed:
- Acceptance Criteria & Reported Device Performance: This document only provides a comparison of design specifications between the applicant's device and a predicate device (Tables 5.1, 5.2, 5.3) for physical dimensions and material. It does not list "acceptance criteria" in the way one would for an AI/CADe system (e.g., sensitivity, specificity, AUC thresholds).
- Study That Proves the Device Meets Acceptance Criteria: The document explicitly states: "Human clinical study was not deemed necessary to support substantial equivalence." and "Panthera Dental Inc. performed no clinical testing." It discusses non-clinical testing like fatigue testing, biocompatibility, and process capability for the physical dental bar, not an AI algorithm.
- Missing Information for AI/CADe devices: The document lacks all the specific details you requested for an AI/CADe study, such as:
- Sample sizes for test sets (it mentions "thirty (30) cylinders" for process capability testing, not an AI test set).
- Data provenance (country of origin, retrospective/prospective).
- Number and qualifications of experts for ground truth.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone algorithm performance.
- Type of ground truth (pathology, outcomes data, etc.).
- Training set sample size and ground truth establishment for the training set.
In summary, the provided document describes a physical dental device, not an AI/CADe system, and thus does not contain the information requested about AI performance metrics or related studies.
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January 26, 2018
Image /page/0/Picture/1 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. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Panthera Dental Inc. Martine Fortin Regulatory Affairs and Quality Assurance Director 2035 rue du Haut-Bord Quebec City, Quebec, G1N 4N7 CANADA
Re: K173466
Trade/Device Name: Panthera Dental Milled Bars Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: November 7, 2017 Received: November 8, 2017
Dear Martine Fortin:
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. 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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K173466
Device Name Panthera Dental Milled Bars
Indications for Use (Describe)
The Panthera Dental Milled Bar is indicated for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient for purpose of restoring function. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained.
The Panthera Dental Milled Bars are indicated for compatibility with the Zimmer Tapered Screw-Vent System for sizes 3.5 and 4.5.
| 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/1 description: The image shows a logo for Panthera Dental. The logo features a black panther in a crouching position above the words "PANTHERA DENTAL" in purple. The word "PANTHERA" is in a larger font than the word "DENTAL".
5. 510 (k) Summary
[As required by 21 CFR 807.92]
| Date Prepared: | January 26, 2018 |
|---|---|
| Submitter: | Panthera Dental Inc.2035 rue du Haut-BordQuebec City (QC) G1N 4R7CanadaFax: +1 (418) 431-9942 |
| Official Contact: | Martine FortinQuality Assurance and Regulatory Affairs Directorregulatory@pantheradental.comTel: +1 (418) 527-0388Fax: +1 (418) 431-9942 |
| Device Trade Name:Device Common Name:Classification:Product: | Panthera Dental Milled BarsOverdenture Bar21 CFR 872.3630 (Class II)NHA |
| Primary predicate: | CAM StructSURE Precision Milled Bars (K080864) |
| Reference predicates: | ISUS Implant Suprastructures (K122424)NobelProcera Overdenture Bar (K132749) |
Description
The Panthera Dental Milled Bar is a metallic dental restorative device which is intended for attaching by screw retention to dental implants to aid in the treatment of partial and totally edentulous patients for the purpose of restoring chewing function.
The Panthera Dental milled bars for which clearance is requested, are included in one of the following bar types, which have distinct design specifications.
The Type I bars are specific for removable overdenture and include:
- Panthera Dental Dolder Bar, Hader Bar, Milled Bar, REBourke Bar and ● Paris Bar.
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Image /page/4/Picture/0 description: The image shows a logo for Panthera Dental. The logo features a black panther in a crouching position above the words "PANTHERA DENTAL". The word "PANTHERA" is in a bold, sans-serif font, and the word "DENTAL" is in a smaller, sans-serif font below it. A purple line is underneath the word "PANTHERA".
The Type II bars are specific for fixed prostheses and include:
- . Panthera Dental Wrap-around Bar, Montreal Bar, Montreal Bar with metallic lingual, Pin Lingual Bar and Pin Wrap-Around Bar.
Table 5.1 presents the design specifications per type of bars.
| Description | Type I | Type II | ||
|---|---|---|---|---|
| Minimum | Maximum | Minimum | Maximum | |
| Platform Seating Diameter | 2 mm | 8 mm | 2 mm | 8 mm |
| Total Cylinders | 2 | 10 | 2 | 10 |
| Bar Span Between Cylinders | 0 mm | 30 mm | 0 mm | 30 mm |
| Bar Height | 2.5 mm1 | 8 mm | 3.5 mm2 | 22 mm |
| Bar Width | 1.5 mm3 | 12 mm4 | 2.5 mm5 | 10 mm6 |
| Distal Extension | 0 mm | 30 mm7 | 0 mm | 30 mm |
| Cylinder Height | 0 mm | 10 mm | ||
| Cylinder Diameter | 3 mm | 8 mm | ||
| Maximum Divergence BetweenCylinders | 0° | 30° |
Table 5.1: Design Specifications of Panthera Dental Bars
The Panthera Dental Milled Bar is designed to match an individual patient. Panthera Dental designs the bar from a three-dimensional optical and/or digital scanner system that scans the casting of a patient's impression: the model cast is prepared beforehand by the dental professional using standard dental techniques. The designed bar is then machined using a computer-aided design/ computer-aided manufacturing software system (CAD/CAM). The bar is milled from titanium (Ti-6AI-4V grade 5). CAD/CAM fabrication is only performed by Panthera Dental, within our manufacturing control and not by the dental laboratory.
The Panthera Dental Milled Bar is packaged as non-sterile, and delivered to a dental laboratory for completion. Once received at the laboratory, the Panthera Dental Milled Bar
2035 rue du Haut-Bord, Québec (Qc), G1N 4R7, Canada, Tel: +1 418-527-0388, free +1 (855) 233-0388 www.pantheradental.com
1 Except for the Panthera Dental Paris Bar that is 3.5 mm.
2 Except for the Panthera Dental Wrap-Around Bar that is 2.5 mm and the Pin Wrap-Around that is 3 mm.
3 Except for the Panthera Dental Dolder Bar that is 1.5 mm; the Hader Bar and Milled Bar that are 1.8 mm and the Paris Bar that is 4 mm.
4 Except for the Panthera Dental Dolder Bar and the Hader Bar that are 5 mm; the Milled Bar that is 10 mm.
5 Except for the Panthera Dental Montreal Bar and the Montreal with Metallic Lingual that are 4 mm.
6 Except for the Panthera Dental Montreal Bar and the Montreal with Metallic Lingual that are 12 mm.
7 Except for the Panthera Dental Dolder Bar and the Hader bar that are 20 mm.
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Image /page/5/Picture/0 description: The image shows a logo for Panthera Dental. The logo features a black panther in a crouching position above the words "PANTHERA DENTAL" in purple. The word "PANTHERA" is in a larger font than the word "DENTAL", and there is a purple line above the word "DENTAL".
is matched to a denture for final placement.
The Panthera Dental Milled Bar provides retention and support for a removable or fixed denture made of standard laboratory dental materials such as resin composite.
Indications for Use
The Panthera Dental Milled Bar is indicated for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient for purpose of restoring chewing function. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained.
The Panthera Dental Milled Bars are indicated for compatibility with the Zimmer Tapered Screw-Vent System for sizes 3.5 and 4.5.
Technological
The following tables (Tables 5.2 and 5.3) display the differences and similarities between the Panthera Dental Milled Bars and a previously marketed (predicate) device. Equivalence is based on similarities in indications for use, materials of construction, design, operating principles, etc.
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Image /page/6/Picture/0 description: The image shows a logo for Panthera Dental. The logo features a black panther in a crouching position above the words "PANTHERA DENTAL" in a stylized font. The word "PANTHERA" is in a larger font than the word "DENTAL", and there is a purple line above the words.
| Feature | The Panthera Dental Milled Bars | CAM StructSURE Precision MilledBars (K080864) | Comparison |
|---|---|---|---|
| Regulationdescription | Endosseous dental implant abutment | Endosseous dental implant abutment | Same |
| Classification | Class II | Class II | Same |
| Indications forUse | As an accessory to an endosseousdental implant to support a prostheticdevice in a partially or edentulouspatient. It is intended for use tosupport multiple tooth prostheses inthemandible or maxilla. Theprostheses can be screw retained.The Panthera Dental Milled Bars areindicated for compatibility with theZimmer Tapered Screw-Vent Systemfor sizes 3.5 and 4.5. | As an accessory to an endosseousdental implant to support a prostheticdevice in a partially or edentulouspatient. It is intended for use to supportmultiple tooth prostheses inthemandible or maxilla. The prosthesescan be screw retained. | Sameexcept foraddition ofthird partycompatibleimplantsystem |
| DeviceMaterial | Titanium alloy Ti-6Al-4V | Titanium alloy Ti-6Al-4V | Same |
| Materials ofconstruction | Highly resilient and durablebiocompatible titanium material andthen manufactured through millingprocess to allow the device to bestrong. The device is lightweight.Single-block | Highly resilient and durablebiocompatible titanium material andthen manufactured through millingprocess to allow the device to be strong.The device is lightweight.Single-block | Same |
| Design/Technology | Use the computer-aided design(CAD) and computer-aidedmanufacturing (CAM).Use CAD that enables a high degreeof customization according to thephysician or dentist prescription toaccommodate the complex dentalanatomy of individual patients. TheCAM and the milling processguarantee precision, accuracy andconsistency for each patient. | Use the computer-aided design (CAD)and computer-aided manufacturing(CAM).Use CAD that enables a high degree ofcustomization according to thephysician or dentist prescription toaccommodate the complex dentalanatomy of individual patients. TheCAM and the milling process guaranteeprecision, accuracy and consistency foreach patient. | Same |
| AnatomicalSite | Oral Cavity | Oral Cavity | Same |
| Design/Construction | Patient specific/ machined | Patient specific/ machined | Same |
| Design MethodBar Order | Individually designed for each patientby order of prescription. | Individually designed for each patientby order of prescription. | Same |
| Sterility | Supplied Non sterile | Supplied Non sterile | Same |
Table 5.2: Comparison chart with the submitted device and the predicate.
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Image /page/7/Picture/0 description: The image shows a logo for a dental company called "Panthera Dental". The logo features a black panther in a crouching position above the company name. The company name is written in a stylized font, with the word "PANTHERA" in a larger font size than the word "DENTAL". A purple line is underneath the company name.
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Image /page/8/Picture/0 description: The image shows the logo for Panthera Dental. The logo features a black panther in a crouching position, with its tail curled up. Below the panther is the word "PANTHERA" in a stylized, purple font. Below "PANTHERA" is the word "DENTAL" in a smaller, simpler font, with a purple line above it.
| Traditional 510(k) — Panthera Dental Milled Bars | |
|---|---|
| Feature | The Panthera Dental Milled Bars | CAM StructSURE Precision Milled Bars (K080864) | Comparison | ||
|---|---|---|---|---|---|
| Targetpopulation | Adults patients | Adults patients | Same | ||
| Prescription/OTC | Prescription only | Prescription only | Same | ||
| RecommendedCleaning andMaintenance | Proper oral hygiene | Proper oral hygiene | Same | ||
| Design matrixforType I bars | Min | Max | Min | Max | |
| PlatformSeatingDiameter | 2 mm | 8 mm | 3.4 mm | 6 mm | Panthera haswider range |
| TotalCylinders | 2 | 10 | 2 | 10 | Same |
| Bar SpanBetweenCylinders | 0 mm | 30 mm | 2 mm | 27 mm | Panthera haswider range |
| Bar Height | 2.58 mm | 8 mm | 2.5 mm | 10 mm | Panthera haslower height |
| Bar Width | 1.59 mm | 1210 mm | 1.8 mm | 10 mm | Panthera haswider range |
| DistalExtension | 0 mm | 3011 mm | 0 mm | 12 mm | Panthera haswider range |
| CylinderHeight | 0 mm | 10 mm | 2.5 mm | 10 mm | Panthera haswider range |
| CylinderDiameter | 3 mm | 8 mm | 3.4 mm | 6 mm | Panthera haswider range |
| MaximumDivergenceBetweenCylinders | 0° | 30° | 0° | 30° | Same |
| Design matrixforType II bars | Min | Max | Min | Max |
8 Except for the Panthera Dental Paris Bar that is 3.5 mm.
2035 rue du Haut-Bord, Québec (Qc), G1N 4R7, Canada, Tel: +1 418-527-0388, free +1 (855) 233-0388
³ Except for the Panthera Dental Dolder Bar that is 1.5 mm; the Hader Bar and Milled Bar that are 1.8 mm and the Paris Bar that is 4 mm.
10 Except for the Panthera Dental Dolder Bar and the Hader Bar that are 5 mm, and the Milled Bar that is 10 mm.
11 Except for the Panthera Dental Dolder Bar and the Panthera Dental Hader bar that is 20 mm.
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Image /page/9/Picture/0 description: The image shows a logo for Panthera Dental. The logo features a black panther in a crouching position above the words "PANTHERA DENTAL". The word "PANTHERA" is in a larger, sans-serif font, and the word "DENTAL" is in a smaller font below it. The text is purple.
| Feature | The Panthera Dental Milled Bars | CAM StructSURE Precision Milled Bars (K080864) | Comparison | ||
|---|---|---|---|---|---|
| Platform Seating Diameter | 2 mm | 8 mm | 3.4 mm | 6 mm | Panthera has wider range |
| Total Cylinders | 2 | 10 | 4 | 10 | Panthera has wider range |
| Bar Span Between Cylinders | 0 mm | 30 mm | 2 mm | 27 mm | Panthera has wider range |
| Bar Height | 3.5 12 mm | 22 mm | 2.5 mm | 22 mm | Panthera has lower range |
| Bar Width | 2.5 13 mm | 10 14 mm | 4 mm | 10 mm | Panthera has wider range |
| Distal Extension | 0 mm | 30 mm | 0 mm | 18 mm | Panthera has wider range |
| A/P Spread | Custom adjustment | 0 mm | 40 mm | Panthera has wider range |
The next table presents the differences and similarities between the specific features and principles of operation for each type of Panthera Dental bars compared with the predicate's bars.
Table 5.3: Comparison chart with the submitted bars and the predicate bars.
| Feature | The Panthera Dental Milled Bars | CAM StructSURE PrecisionMilled Bars (K080864) | Comparison | |
|---|---|---|---|---|
| Dolde | Features | Use for smaller mouth.Removable overdenture. | Removable denture design with clipsfor more rigid fit.Clips allow for anterior/ posteriorrotation of the denture. | Similar |
| Principles ofoperation | Riders are fixed in the denture to clip it tothe bar. This allows the patient to easilyremove the denture for cleaning. | |||
| Shape | ||||
| lade | Features | Use for smaller mouth.Removable overdenture. | Remove overdenture design withclips that engage undercuts.Provides some lateral stability. | Similar |
| Feature | The Panthera Dental Milled Bars | CAM StructSURE Precision Milled Bars (K080864) | Comparison | |
| Milled | Principles of operation | Riders with nylons that can be changed when needed are fixed in the denture to clip it to the bar. This allows the patient to easily remove the denture for cleaning. | 4 mm between implants needed for clips | |
| Shape | Image: Keyhole shape | Image: Shape with a line on top and curved bottom | ||
| Features | Inclining wall angles of anywhere between 0.5° and 10°.Removable overdenture. | May be used with attachments or secondary casting.Bar can be designed with a 2°- 6° taper. | ||
| Milled | Principles of operation | The attachments are installed on the bar to clip it to the denture with caps. May be used with attachments or secondary structure. This allows the patient to easily remove the denture for cleaning. | N/A | Similar |
| Shape | Image: Trapezoid shape | N/A | ||
| Paris | Features | A hybrid combination of a removable bar with the great finish of a Montreal-type fixed.Removable overdenture. | N/A | |
| Principles of operation | The attachments are installed on the bar to clip it to the denture with caps. This allows the patient to easily remove the denture for cleaning. | N/A | N/A | |
| Paris | Shape | Image: Shape with a thick base and a thinner top | N/A | |
| Wrap-Around | Features | Optimal form with rounded edges.Predetermined height that follows the tissue line.Fixed overdenture. | Fixed prosthesis. | |
| Feature | The Panthera Dental Milled Bars | CAM StructSURE PrecisionMilled Bars (K080864) | Comparison | |
| Montreal | Principles of operation | The acrylic denture wraps around the barand is then fixed to the implants with thehelp of screws and can only be removed bythe practitioner. | Acrylic resin wraps around the bar. | |
| Shape | Image: Y shape | Image: Rectangle shape | ||
| Features | Predetermined height that follows thetissue line.Fixed overdenture. | Fixed hybrid bar.Removable prosthesis engages bar.Called the Canada Bar. | ||
| Montreal | Principles of operation | The acrylic denture wraps around the barand is then fixed to the implants with thehelp of screws and can only be removed bythe practitioner. | Acrylic resin wraps around the bar. | Similar |
| Shape | Image: Plus shape | Image: Trapezoid shape | ||
| Montreal with Metallic Lingual | Features | Fixed overdenture. | N/A | |
| Principles of operation | The acrylic denture sits on the bar and isretained by the pins. Individual tooth areinserted in the pins for a better retention.The bar is fixed to the implants withscrews. | N/A | N/A | |
| Shape | Image: Shape | N/A | ||
| Pin Lingual | Features | Additional support for each individualtooth. Pins are align within the center ofeach tooth of the master model.Fixed overdenture. | N/A | N/A |
| Feature | The Panthera Dental Milled Bars | CAM StructSURE Precision Milled Bars (K080864) | Comparison | |
| Principles of operation | The acrylic denture sits on the bar and is retained by the pins. Individual tooth are inserted in the pins for a better retention. The bar is fixed to the implants with screws. | N/A | ||
| Shape | Image: drawing of a dental bar with pins | N/A | ||
| Pin Wrap-Around | Features | Additional support for each individual tooth. Pins are aligned with the center of each tooth of the master model. Fixed overdenture. | N/A | N/A |
| Principles of operation | The acrylic denture is wrapped around the bar and individual tooth are inserted in the pins for a better retention. The bar is fixed to the implants with screws. | N/A | ||
| Shape | Image: drawing of a dental bar with pins | N/A | ||
| REBourke concept | Features | Allow patients to benefit from the advantages of both removable and fixed restorations. Primary bar designed with a 25 degree angulation to allow an easy path of insertion and avoid movement on the occlusal axis. | N/A | N/A |
| Principles of operation | The primary bar is fixed in the mouth with the help of screws in the implants. The secondary bar is wrapped by the acrylic to form the denture. The friction between the two structures is what maintains both bars without any possibility of movement. In order to secure everything together, MK1 attachments are used in the posterior area, giving the patient the same feeling as a fixed restoration. This allow the patient to easily remove the denture for cleaning. | N/A | ||
| Shape | N/A | N/A |
12 Except for the Panthera Dental Wrap-Around Bar that is 2.5 mm and the Panthera Dental Pin Wrap-Around that is 3 mm.
43 Except for the Panthera Dental Montreal Bar and the Montreal with Metallic Lingual that is 4 mm.
2035 rue du Haut-Bord, Québec (Qc), G1N 4R7, Canada, Tel: +1 418-527-0388, free +1 (855) 233-0388 www.pantheradental.com
14 Except for the Panthera Dental Montreal Bar and the Montreal with Metallic Lingual that is 12 mm.
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Image /page/10/Picture/0 description: The image shows a logo for a dental company called Panthera Dental. The logo features a black panther in a crouching position above the company name. The company name is written in a sans-serif font, with the word "PANTHERA" in a larger font size than the word "DENTAL". A horizontal line is placed above the word "DENTAL".
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Image /page/11/Picture/0 description: The image shows a logo for a dental company called Panthera Dental. The logo features a black panther in a crouching position above the company name. The company name is written in a sans-serif font, with the word "PANTHERA" in a larger font size than the word "DENTAL". A horizontal line separates the two words.
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Image /page/12/Picture/0 description: The image shows a logo for Panthera Dental. The logo features a black panther in a crouching position above the words "PANTHERA DENTAL" in a purple sans-serif font. The panther is silhouetted and appears to be stalking or preparing to pounce.
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Panthera Dental Inc. performed no clinical testing. However, a FMEA risk analysis, and evaluation of the materials of construction and the design were performed. The function of the bars requires that the prescribing dentist is cognizant of the potential for soreness, soft tissue soreness, and dentition complications by the bars. Management of these risks is achieved by advising the patient and dentist in the directions for use that early and repeated examination of the performance of the device, and its fit, must be performed in the dental office by the prescribing dentist. The precautions, storage directions and prescription preparation instructions are written to avoid potential problems from arising or persisting with the dentition or tissue, caused by the bars. The proprietary manufacturing of the Panthera Dental bar includes materials for the milling, the polishing and the cleaning that are biocompatible and from standard manufacturing in dental practices. This manufacturing process does not alter the chemical or physical properties of the Panthera Dental bar. No new risks are introduced with the new device that are not present in the predicate device.
Non-Clinical Testing
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 predicate device.
Sterilization
A sterilization validation was performed. The complete validation of the pre-vacuum steam sterilization cycle has been performed.
The first part of the validation consisted in the validation of the sterility test used to test the sterility of the dental bars after the sterilization cycle; validation parameters where based on USP<71> (Sterility Tests). In the second part, the sterility test has demonstrated that the Panthera Dental bars were sterile once the above cycle was completed. The sterilization test was performed in an FDA cleared sterilizer (# K111223), Amsco Chimeron Small Prevacuum Steam Sterilizer. Based on the effectiveness statement of this sterilizer, the Prevac cycle was validated using full load instrument trays, described in 5.5.4.1 of ANSI/AAMI-ST8, and was qualified according to Section 5.5.4 of ANSI/AAMI-ST8. This cycle demonstrated a sterility assurance level of at least 10-6 using half-cycle analysis. The sterilization process is a typical steam autoclave sterilization process, it does not alter the chemical or physical properties of the Panthera Dental bar.
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Image /page/14/Picture/0 description: The image shows a logo for Panthera Dental. The logo features a black panther in a crouching position, with its tail curled up. Below the panther, the word "PANTHERA" is written in a purple sans-serif font, with the word "DENTAL" in a smaller font below it.
Biocompatibility
The biocompatibility analysis provided herein supports the substantial equivalence in the safety and effectiveness of the predicate device. The raw material used in the manufacturing of the Panthera Dental bar is the same as for the predicate device: Titanium Ti-6Al-4V. Both Panthera Dental bar and the predicate bar are categorized as external communicating devices that contact tissue/bone/dentin for more than 30 days. The cytotoxicity, the extractable chemical analysis, the toxicological risk assessment and the bacterial endotoxins testing performed with the Panthera Dental bars support substantial equivalence to the predicate, following the standards of ISO 10993-1, ISO 10993-5, ISO 10993-12, ANSI/AAMI ST72, and USP <85>. Therefore we believe that the new device is as safe as the legally marketed device.
FEA
Finite Element Analysis (FEA) was done on the dental bar prior to starting any testing.
Fatigue Testing
Fatigue testing was performed on the Panthera Dental bar: two (2) static and two (2) dynamic tests were completed. The first test was performed on the bar itself (cantilever section of the bar) and the second one was performed on the bar cylinders. The testing was performed in accordance with the ISO 14801 standard (Dentistry - Implants-Dynamic fatigue test for endosseous dental implants) and the FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments; guidance for industry and FDA." The results have demonstrated that the Panthera Dental Milled Bar as well as the cylinders constituting the bar, have sufficient mechanical strength for its intended clinical application.
Reverse engineering analysis
Panthera Dental has used the RE method to determine the critical parameters of the design of each interface connection including the tolerance limits between each components per size and type, for the Zimmer TSV system. This rigorous reverse engineering of all the components has generated the critical parameters as well as the manufacturing tolerances for Zimmer TSV device interface connection. With those in hand, it was possible to reproduce an exact copy of the Zimmer TSV cylinder's interface connection and to ensure a compatible fit between the proposed cylinder and their Zimmer TSV reverse engineered counterparts (OEM implant bodies, OEM abutments, and OEM fixation screws).
The RE of the three Zimmer components: OEM implant bodies, OEM abutments, and OEM fixation screws, gives the assurance that the RE values of the connection interfaces of our proposed device fall within the measured sizes of the counterpart Zimmer implants/ screws and confirms that the Panthera Dental assemblies will always be functional with no possible interference. To complete the
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Image /page/15/Picture/0 description: The image shows a logo for a dental company called "Panthera Dental". The logo features a black panther in a crouching position above the company name. The company name is written in a stylized font, with the word "PANTHERA" in a larger font size than the word "DENTAL". The color of the company name is purple.
RE, the different gaps were verified in the final Panthera assemblies and confirms proper seating of the cylinder on the implant as well as the insertion and the seating of the screw in the cylinder.
Process capability study
In order to confirm the reliability of the manufacturing process of the Panthera Dental bars, a process capability test was performed. This test allows the determination of the capability index and therefore indicates the level at which the CAD/CAM manufacturing process is able to perform considering every inherent natural variation of each step of the whole manufacturing workflow. Thirty (30) cylinders were manufactured and measured to determine the Cpk value of each of their critical dimensions. The milling process successfully passed the standards with a Cnk value higher than 1.0 for each critical dimension. This test also showed that even with a worst-case process mean shift of 1.50, the manufactured bar's cylinders from Panthera Dental's CAD/CAM milling process do not exceed the specification limits. The process is therefore reliable for the manufacturing of the Panthera Dental Milled Bars.
Clinical Testing
Human clinical study was not deemed necessary to support substantial equivalence. The Panthera Dental Milled Bars do not: use designs dissimilar from the predicate device and other previously cleared devices under a 510(k); do not use new technologies different from legally marketed milled bars; and do not deviate from the indications for use identified in the predicate device: CAM StructSURE Precision Milled Bars.
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Image /page/16/Picture/0 description: The image shows a logo for Panthera Dental. The logo features a black silhouette of a panther in a crouching or stalking position. Below the panther, the word "PANTHERA" is written in a bold, sans-serif font, with the word "DENTAL" in a smaller font size underneath it. The word "PANTHERA" and the line under it are purple.
Substantial Equivalence Conclusion
The new device, Panthera Dental Milled Bar, is considered to be substantially equivalent to the predicate based on the following: it has essentially the same indications for use and is indicated for the same user population; it uses biocompatible material for the manufacturing, as the predicate does; the manufacturing process does not alter the biocompatibility of the device; and it has equivalent technological characteristics to those of the predicate.
§ 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.)