(181 days)
K173466 Panthera Dental Milled Bars
No
The description focuses on CAD/CAM design and milling from scanned impressions, with no mention of AI or ML for design or analysis.
No
The device is described as a "metallic dental restorative device that 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," which indicates a restorative, rather than therapeutic, purpose.
No
The device is a restorative dental component (milled bar) used to support prostheses, not to diagnose a condition.
No
The device is a physical metallic dental restorative device (milled bar) that is designed and manufactured using CAD/CAM software, but the final product is a tangible hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to support a prosthetic device in a patient to restore function (chewing). This is a direct clinical application within the body, not a test performed on a sample taken from the body.
- Device Description: The device is a metallic dental restorative device designed to be attached to dental implants. It is a physical component used in a surgical/restorative procedure.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. It is a treatment device.
- No Mention of Samples: IVD devices typically involve testing biological samples (blood, urine, tissue, etc.). This device interacts directly with the patient's anatomy.
The device is clearly a medical device used in dentistry for restorative purposes, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 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:
- · Standard/Standard Plus RN- Ø 4.1/4.8 (platform Ø 4.8)
- · Standard/ Standard Plus/Tapered Effect WN Ø 4.8 (platform Ø 6.5)
- · Tapered Effect RN Ø 4.1 (platform Ø 4.8)
- · Bone Level/ Bone Level Tapered NC Ø 3.3 (platform Ø 3.3)
- · Bone Level/ Bone Level Tapered RC Ø 4.1. 4.8 (platforms Ø 4.1 and 4.8)
Product codes
NHA
Device Description
The Panthera Dental Milled Bar is a metallic dental restorative device that 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 patient's impression; the dental professional prepares the model cast beforehand. The designed bar is then machined using a computer-aided design/ computer-aided manufacturing (CAD/CAM) software system. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical and/or digital scanner system
Anatomical Site
mandible or maxilla
Indicated Patient Age Range
Adults patients
Intended User / Care Setting
Dental professional, Dental laboratory
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 Testing:
- Sterilization validation: Conducted for the primary predicate (K173466) using a pre-vacuum steam sterilization cycle for wrapped instruments for 4 minutes at 132°C followed by a 30-minute drying period. The sterility test demonstrated that the Panthera Dental bars were sterile. The process demonstrated a sterility assurance level of at least 10-0.
- Biocompatibility analysis: Conducted for the primary predicate (K173466). The raw material is Titanium Ti-6Al-4V. Tests performed included cytotoxicity, extractable/leachable chemical analysis, toxicological risk assessment, and bacterial endotoxins testing, following ISO 10993-1, ISO 10993-5, ISO 10993-12, ANSI/AAMI ST72, and USP .
- Finite Element Analysis (FEA): Done on the bar cylinders.
- Fatigue Testing: First test performed on the bar itself, second on the bar cylinders. Performed in accordance with ISO 14801 and FDA guidance "Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Implant Abutments; guidance for industry and FDA." Results demonstrated the mechanical strength of the bars and cylinders for their intended clinical application.
- Reverse engineering analysis: Performed to determine critical parameters of the design of each interface connection, including tolerance limits, between components per size and type, for Straumann implant systems. Confirmed proper seating of the cylinder on the implant and insertion/seating of the screw.
- Process Capability Study: Conducted for the primary predicate (K173466) to confirm the reliability of the manufacturing process.
Clinical Testing:
Human clinical study was not deemed necessary to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K173466 Panthera Dental Milled Bars
Reference Device(s)
K140737 Straumann CARES Screw-Retained Bars/Bridges, K171784 Straumann Dental Implant System, K140878 Straumann Bone Level Tapered Implant Roxolid SLActive
Predetermined Change Control Plan (PCCP) - All Relevant Information
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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 20, 2019
Panthera Dental Inc. Martine Fortin Director Regulatory Affairs and Quality Assurance 2035 rue du Haut-Bord Quebec City (QC) G1N 4R7 CANADA
Re: K183580
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: May 15, 2019 Received: May 16, 2019
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. 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.
for Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental 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) K183580
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:
- · Standard/Standard Plus RN- Ø 4.1/4.8 (platform Ø 4.8)
- · Standard/ Standard Plus/Tapered Effect WN Ø 4.8 (platform Ø 6.5)
- · Tapered Effect RN Ø 4.1 (platform Ø 4.8)
- · Bone Level/ Bone Level Tapered NC Ø 3.3 (platform Ø 3.3)
- · Bone Level/ Bone Level Tapered RC Ø 4.1. 4.8 (platforms Ø 4.1 and 4.8)
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, with its tail curled up. Below the panther, the word "PANTHERA" is written in a stylized font, with the word "DENTAL" written in a smaller font below it. The words are in a purple color.
5 510 (k) Summary
| Date Prepared: | June 19, 2019 |
|---|---|
| Submitter: | Panthera Dental Inc. |
| 2035 rue du Haut-Bord | |
| Quebec City (QC) G1N 4R7 | |
| Canada | |
| Official Contact: | Martine Fortin |
| Director Regulatory Affairs and Quality Assurance | |
| regulatory@pantheradental.com | |
| Tel: +1 (418) 527-0388 | |
| Fax: +1 (418) 431-9942 | |
| Proprietary Name: | Panthera Dental Milled Bars |
| Device Common Name: | Overdenture Bar |
| Classification: | 21 CFR 872.3630 (Class II) |
| Product: | NHA |
| Primary Predicate: | K173466 Panthera Dental Milled Bars |
| Reference Devices: | K140737 Straumann CARES Screw-Retained Bars/Bridges |
| K171784 Straumann Dental Implant System | |
| K140878 Straumann Bone Level Tapered Implant Roxolid | |
| SLActive |
5.1 Description
The Panthera Dental Milled Bar is a metallic dental restorative device that 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/1 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 stylized purple font, with the word "DENTAL" written in a smaller font below it. The logo is simple and modern, and the use of the panther suggests strength and agility.
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 bar types.
| Type I | Type II | |||
|---|---|---|---|---|
| Description | Minimum | Maximum | Minimum | Maximum |
| Platform Seating Diameter (mm) | 2 | 8 | 2 | 8 |
| Total Cylinders | 2 | 10 | 2 | 10 |
| Bar Span Between Cylinders (mm) | 0 | 30 | 0 | 30 |
| Bar Height (mm) | 2.51 | 8 | 3.52 | 22 |
| Bar Width (mm) | 1.53 | 124 | 2.55 | 106 |
| Distal Extension (mm) | 0 | 307 | 0 | 30 |
| Cylinder Height (mm) | 0 | 10 | ||
| Cylinder Diameter (mm) | 3 | 8 | ||
| Maximum Divergence Between | ||||
| Cylinders | 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 patient's impression; the dental professional prepares the model cast beforehand. The designed bar is then machined using a computer-aided design/ computer-aided manufacturing (CAD/CAM) software system. 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
1 Except for the Paris Bar that is 3.5 mm.
2 Except for the Wrap-Around Bar that is 2.5 mm and the Pin Wrap-Around that is 3 mm.
3 Except for the Dolder Bar that is 1.5 mm; the Hader and Milled Bars that are 1.8 mm and the Paris Bar that is 4 mm.
4 Except for the Dolder Bar and the Hader Bar that are 5 mm; the Milled Bar that is 10 mm.
5 Except for the Montreal Bar and the Montreal with Metallic Lingual that are 4 mm.
6 Except for the Montreal Bar and the Montreal with Metallic Lingual that are 12 mm.
7 Except for the Dolder Bar and the Hader bar that are 20 mm.
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Image /page/5/Picture/1 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 purple, with the word "Panthera" in a larger font size than the word "Dental". The panther is sleek and muscular, with a long tail that curves upwards.
retention and support for a removable or fixed denture made of standard laboratory dental materials such as resin composite.
The Panthera Dental Milled Bars are indicated for compatibility with the following Straumann implant system platforms:
S/SP/TE RN (platform Ø 4.8); S/SP/TE WN (platform Ø 6.5); BL/BLT NC (platform Ø 3.3); BL/BLT RC (platforms Ø 4.1 and 4.8), cleared under K171784, K140878 and K111357.
5.2 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:
- Standard/Standard Plus RN Ø 4.1/4.8 (platform Ø 4.8)
- Standard/ Standard Plus/Tapered Effect WN Ø 4.8 (platform Ø 6.5)
- · Tapered Effect RN Ø 4.1 (platform Ø 4.8)
- · Bone Level/ Bone Level Tapered NC Ø 3.3 (platform Ø 3.3)
- · Bone Level/ Bone Level Tapered RC Ø 4.1, 4.8 (platforms Ø 4.1 and 4.8)
5.3 Technological
Aside from incorporating features to facilitate connection to Straumann bone and tissue level implant systems, the materials, design, operating principles, manufacturing and sterilization method are identical to those of the primary predicate intended for use with Zimmer implant systems. No new surgical instruments or secondary components are being introduced as a result of this submission. The specific features from the proposed device allow a perfect connection between the Panthera bar cylinder and the Straumann implant necessary to meet the intended use that is to support a prosthetic device in the mandible or maxilla, in a partially or edentulous patient. The additional Straumann implant systems compatibility do not add new bar designs, in fact, the same bar designs are available for both OEM (Zimmer and Straumann). Therefore, we believe that the new device is substantially equivalent to the primary predicate.
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Image /page/6/Picture/0 description: The image shows the logo for Panthera Dental. The logo features a black silhouette of a panther in a stalking pose, with glowing white eyes. Below the panther, the word "PANTHERA" is written in a bold, purple sans-serif font, with the word "DENTAL" in a smaller font size underneath.
Abbreviated 510(k) – Panthera Dental Milled Bars
Table 5.2: Comparison chart between the proposed device and the reference devices
| Feature | The Panthera Dental
Milled Bars
(proposed device) | The Panthera Dental Milled
Bars
(Primary Predicate
K173466) | Straumann CARES
Screw-Retained
Bars/Bridges
(K140737) | Straumann Dental
Implant System
(K171784, K140878) | Comparison |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------|---------------------------------------------------------------------------------------|
| Regulation
description | Endosseous dental implant
abutment | Endosseous dental implant
abutment | Endosseous dental
implant abutment | Endosseous dental
implant | Same for proposed
and predicate |
| Indications for Use | 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
Straumann tissue level and
bone level systems. | 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 | N/A | N/A | Same for proposed
and predicate
except for the
compatible implant
systems |
| Device Material | Titanium alloy Ti-6Al-4V,
biocompatible | Titanium alloy Ti-6Al-4V,
biocompatible | N/A | N/A | Same for proposed
and predicate |
| Design/ Technology | CAD/CAM milling from
single milling blanks. | CAD/CAM milling from single
milling blanks. | CAD/CAM milling from
milling blanks. | N/A | Same for proposed
and predicate |
| Design/
Construction | Patient specific/ machined | Patient specific/ machined | Patient specific/
machined | N/A | Same for proposed
and predicate |
| Sterility | Supplied Non sterile | Supplied Non sterile | N/A | Sterile | Same for proposed
and predicate |
| Target population | Adults patients | Adults patients | Adults patients | N/A | Same for proposed
and predicate |
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Image /page/7/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 word "PANTHERA" is larger and bolder than the word "DENTAL", and there is a purple line above the words.
Abbreviated 510(k) – Panthera Dental Milled Bars
| Feature | The Panthera Dental
Milled Bars
(proposed device) | The Panthera Dental Milled
Bars
(Primary Predicate
K173466) | Straumann CARES
Screw-Retained
Bars/Bridges
(K140737) | Straumann Dental
Implant System
(K171784, K140878) | Comparison |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Prescription/ OTC | Prescription only | Prescription only | Prescription only | N/A | Same for proposed
and predicate |
| Recommended
Cleaning and
Maintenance | Proper oral hygiene | Proper oral hygiene | Not applicable | Not applicable | Same for proposed
and predicate |
| Implant Interface
Type/implant
diameter (mm) | • S/SP RN – Ø 4.1/4.8
(platform Ø 4.8)
• S/SP/TE WN – Ø 4.8
(platform Ø 6.5)
• TE RN - Ø 4.1 (platform Ø 4.8)
• BL/BLT NC - Ø 3.3
(platform Ø 3.3)
• BL/BLT RC - Ø 4.1, 4.8
(platforms Ø 4.1 and 4.8) | Zimmer implant systems | Straumann:
Bone Level (BL)
implants and Tissue
Level (TL) implants | Straumann:
S/SP/TE, Ø3.3 RN;
S/SP/TE, Ø4.1 RN;
S/SP, Ø4.8 RN;
S/SP/TE, Ø4.8 WN;
BL/BLT, Ø3.3 NC,
Ø4.1 RC, and Ø4.8 RC | Same for proposed
and the 3 reference
devices |
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Image /page/8/Picture/1 description: The image shows a logo for "Panthera Dental". The logo features a black silhouette of a panther in a crouching or stalking pose above the company name. The word "PANTHERA" is written in a stylized, sans-serif font in a purple color, and below it, the word "DENTAL" is written in a smaller, simpler font with a line above it.
5.4 Risks
Panthera Dental Inc. did not performed 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 the prescribing dentist must perform early and repeated examination of the performance of the device, and its fit, in the dental office. 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 primary predicate device.
ર્ડ 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 primary predicate device.
5.5.1 Sterilization
A sterilization validation was conducted for the primary predicate (K173466). The complete validation of the following steam autoclave sterilization process has been conducted: Pre-vacuum steam sterilization cycle for wrapped instruments for 4 minutes, at 132°C followed by a drying period of 30 minutes.
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 (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 ANSVAAMI-ST8, and was qualified according to Section 5.5.4 of ANSI/AAMI-ST8. This cycle demonstrated a sterility assurance level of at least 10-0 using half-cycle analysis. The
2035 rue du Haut-Bord, Québec (Qc), G1N 4R7, Canada, Tel: +1 418-527-0388
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Image /page/9/Picture/1 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 above the word "DENTAL".
sterilization process is a typical steam autoclave sterilization process, it does not alter the chemical or physical properties of the Panthera Dental bar.
The complete sterility testing conducted for the primary predicate (K173466) used the same materials and the same sterilization cycle as for the proposed device. Therefore, no additional sterility testing was required for the proposed device.
5.5.2 Biocompatibility
The biocompatibility analysis conducted for the primary predicate (K173466) 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/leachable 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 . Therefore, we believe that the new device is as safe as the legally marketed device.
5.5.3 FEA
Finite Element Analysis (FEA) was done on the bar cylinders prior to starting any testing.
Fatigue Testing 5.5.4
Fatigue testing was performed on the Panthera Dental bar. The first test was performed on the bar itself as part of the primary predicate submission (cleared K173466). The second one was performed on the bar cylinders. The testing was performed in accordance with the ISO 14801standard "Dentistry - Implants-Dynamic fatigue test for endosseous dental implants" and the FDA guidance "Class II Special Controls Guidance Document: Rootform 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 the mechanical strength for its intended clinical application.
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Image /page/10/Picture/1 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 purple, with the word "DENTAL" written in a smaller font size below it.
5.5.5 Reverse engineering analysis
Panthera Dental has used the reverse engineering (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 Straumann implant systems, including OEM Implant bodies, OEM abutments, and OEM abutment fixation screws. With those in hand, it was possible to reproduce an exact copy of the Straumann cylinder's interface connection and to ensure a perfect fit between the proposed cylinder and its Straumann RE counterparts (implant and screw).
The RE of the Straumann components gives the assurance that the RE values of the connection interfaces of our proposed device fall within the measured sizes of the Straumann counterparts and confirms that the Pantal assemblies will always be functional with no possible interference. To complete the RE, the different gaps were verified in the final Panthera assemblies and confirmed proper seating of the cylinder on the implant as well as the insertion and the seating of the screw in the cylinder. The RE analysis performed for the proposed device is identical to the one performed for the primary predicate.
Process capability study 5.5.6
In order to confirm the reliability of the manufacturing process of the Panthera Dental bar, a process capability test was conducted for the primary predicate (K173466). This test is valid for the proposed device because the manufacturing process is identical for both the proposed and the primary predicate device.
5.6 Clinical Testing
Human clinical study was not deemed necessary to support substantial equivalence. The Panthera Dental Milled Bar do not: use designs dissimilar from the primary predicate device; do not use new technologies different from legally marketed milled bars; and do not deviate from the indications for use identified in the primary predicate device: Panthera Dental Milled Bar K173466.
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Image /page/11/Picture/1 description: The image shows a logo for Panthera Dental. The logo features a black panther in a crouching position, ready to pounce. Below the panther, the word "PANTHERA" is written in a stylized font, with the word "DENTAL" underneath in a smaller font. The word "PANTHERA" and the line under the word "DENTAL" are purple.
Substantial Equivalence Conclusion 5.7
The new device, the Panthera Dental Milled Bar, is considered substantially equivalent to the primary predicate device based on the following. Both devices (proposed and primary predicate) have the same indications for use and are indicated for the same user population; use the same operating principle; incorporate the same basic design: use the same biocompatible material and the same manufacturing process; and have the same technological characteristics.