(247 days)
No
The description focuses on CAD/CAM technology for design and milling, which is a traditional digital manufacturing process and does not inherently involve AI/ML. There is no mention of AI, ML, or related concepts in the document.
No
Explanation: The device is a dental restorative component (milled bar) that attaches to dental implants to support prostheses for restoring chewing function. It is an accessory to an implant, not a primary therapeutic device itself.
No
The device is described as a "metallic dental restorative device" intended to "support a prosthetic device" and "restoring chewing function." It is a structural component that aids in the treatment, not a device used to identify or analyze a condition.
No
The device is a metallic dental restorative device that is physically milled from titanium, making it a hardware device. While it utilizes CAD/CAM software in its manufacturing process, the final product is a physical 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 chewing function. This is a mechanical function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a metallic dental restorative device used for attaching to dental implants. It is a physical component for a dental prosthesis.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a disease, condition, or state of health. It does not analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
- Focus on Mechanical Support: The description and testing focus on the mechanical properties and compatibility of the bar for supporting a dental prosthesis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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:
- · NobelActive: NP Ø3.5; RP Ø4.3 / Ø5.0; WP Ø5.5
- NobelParallel CC: NP Ø3.75: RP Ø4.3 / Ø5.0: WP Ø5.5
- NobelReplace: NP Ø3.5; RP Ø4.0 / Ø4.3 / Ø5.0; WP Ø5.0; 6 Ø6.0
- NobelSpeedy: RP Ø4.0 / Ø5.0; WP Ø5.0 / Ø6.0
- Brånemark: NP Ø3.3; RP Ø3.75 / Ø4.0; WP Ø5.0
Product codes (comma separated list FDA assigned to the subject device)
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.
The Panthera Dental Milled Bars are indicated for compatibility with the following Nobel Biocare implant system platforms:
NobelActive/ Parallel CC/ Speedy/ Brånemark: NP/RP/WP; NobelReplace: NP/RP/WP/6; cleared under K071370, K133731, K173418, K062566, K073142, K023113, K050406, K160119 and K022562.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or maxilla
Indicated Patient Age Range
Not Found
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: 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 sterility test 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. This cycle demonstrated a sterility assurance level of at least 10^-6 using half-cycle analysis.
- Biocompatibility: The biocompatibility analysis conducted for the primary predicate (K173466) supports the substantial equivalence. The raw material used is Titanium Ti-6Al-4V. The cytotoxicity, extractable/leachable chemical analysis, toxicological risk assessment and bacterial endotoxins testing performed with the Panthera Dental bars support substantial equivalence to the predicate.
- FEA: Finite Element Analysis (FEA) was done on the bar cylinders.
- Fatigue Testing: Fatigue testing was performed on the Panthera Dental bar as part of the primary predicate submission (K173466) and on the bar cylinders. 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.
- Reverse engineering analysis (RE): RE was used 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 Nobel Biocare implant systems. The RE of the Nobel Biocare components gives the assurance that the RE values of the connection interfaces of our proposed device fall within the measured sizes of the Nobel Biocare counterparts and confirms that the Pantal assemblies will always be functional with no possible interference.
- Process capability study: A process capability test was conducted for the primary predicate (K173466) to confirm the reliability of the manufacturing process. This test is valid for the proposed device because the manufacturing process is identical for both devices.
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): 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.
K173466 Panthera Dental Milled Bars
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.
K071370, K133731 NobelActive, K173418 NobelParallel Conical Connection, K062566, K073142, K023113 NobelReplace, K050406, K160119 NobelSpeedy, K022562
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 8, 2020
Panthera Dental Inc. Martine Fortin Director Regulatory Affairs and Ouality Assurance 9105 rue John-Simons Quebec City, Québec, G2B 0S6 CANADA
Re: K192108
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: March 6, 2020 Received: March 11, 2020
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 (OS) 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. 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) K192108
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:
- · NobelActive: NP Ø3.5; RP Ø4.3 / Ø5.0; WP Ø5.5
- NobelParallel CC: NP Ø3.75: RP Ø4.3 / Ø5.0: WP Ø5.5
- NobelReplace: NP Ø3.5; RP Ø4.0 / Ø4.3 / Ø5.0; WP Ø5.0; 6 Ø6.0
- NobelSpeedy: RP Ø4.0 / Ø5.0; WP Ø5.0 / Ø6.0
- Brånemark: NP Ø3.3; RP Ø3.75 / Ø4.0; WP Ø5.0
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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 a logo for Panthera Dental. The logo features a black silhouette of a panther in a crouching position, ready to pounce. Below the panther is the word "PANTHERA" in a bold, sans-serif font, with the word "DENTAL" in a smaller font underneath. A purple line underlines the word "PANTHERA".
510 (k) Summary 5
| Date Prepared: | April 7, 2020 |
|---|---|
| Submitter: | Panthera Dental Inc. |
| 9105 rue John-Simons | |
| Quebec City (QC) G2B 0S6 | |
| 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 Code: | NHA |
| Primary Predicate: | K173466 Panthera Dental Milled Bars |
| Reference Devices: | K071370, K133731 NobelActive |
| K173418 NobelParallel Conical Connection | |
| K062566, K073142, K023113 NobelReplace | |
| K050406, K160119 NobelSpeedy |
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.
9105 rue John-Simons, Québec (Qc), G2B 0S6, Canada, Tel: +1 418-527-0388
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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, with its tail curled up. Below the panther, the word "PANTHERA" is written in a purple sans-serif font, with the word "DENTAL" written in a smaller font below it.
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/0 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 bold, purple font, with the word "DENTAL" written in a smaller font below it.
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 Nobel Biocare implant system platforms:
NobelActive/ Parallel CC/ Speedy/ Brånemark: NP/RP/WP; NobelReplace: NP/RP/WP/6; cleared under K071370, K133731, K173418, K062566, K073142, K023113, K050406, K160119 and K022562.
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:
NobelActive: NP Ø3.5; RP Ø4.3 / Ø5.0; WP Ø5.5 NobelParallel CC: NP Ø3.75; RP Ø4.3 / Ø5.0; WP Ø5.5 NobelReplace: NP Ø3.5; RP Ø4.0 / Ø4.3 / Ø5.0; WP Ø5.0; 6 Ø6.0 NobelSpeedy: RP Ø4.0 / Ø5.0; WP Ø5.0 / Ø6.0 Brånemark: NP Ø3.3; RP Ø3.75 / Ø4.0; WP Ø5.0
Technological 5.3
Aside from incorporating features to facilitate connection to Nobel Biocare 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 Nobel Biocare 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 Nobel Biocare implant systems compatibility do not add new bar designs, in fact, the same bar designs are available for both OEM (Zimmer and Nobel Biocare). 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 a logo for Panthera Dental. The logo features a black silhouette of a panther in a stalking pose, with its tail curved upwards. Below the panther, the word "PANTHERA" is written in a stylized, sans-serif font, with the letters in a light purple color. Underneath "PANTHERA", the word "DENTAL" is written in a smaller, simpler font, also in light purple.
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) | NobelActive
(K071370, K133731),
NobelParallel CC
(K173418) | NobelReplace
(K062566,
K073142, K023113) | NobelSpeedy
(K160119 incl.
K050406) | Brånemark
(K022562) |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation
description | Endosseous dental
implant abutment | Endosseous dental
implant abutment | Endosseous dental
implant | Endosseous dental
implant | Endosseous dental
implant | Endosseous dental
implant |
| 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
Nobel Biocare 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 | NobelActive: As
endosseous implant
intended to be surgically
placed in the bone of the
upper or lower jaw
arches to provide
support for prosthetic
devices, such as an
artificial tooth, in order
to restore patient
esthetics and chewing
function. Indicated for
single or multiple unit
restorations in splinted
or non-splinted
applications. May be
placed immediately and
put into immediate
function provided that
initial stability
requirements detailed in
the manual are satisfied. | As endosseous dental
implants intended to
be surgically placed in
the bone of the upper
or lower jaw arches to
provide support for
prosthetic devices,
such as an artificial
tooth, in order to
restore patient
esthetics and chewing
function. Indicated for
single or multiple unit
restorations. Can be
used in splinted or
nonsplinted
applications. May be
placed immediately
and put into immediate
function provided that
initial stability
requirements detailed
in the manual are
satisfied. | K050406: Intended to
be surgically placed in
the bone of the upper or
lower jaw arches to
provide support for
prosthetic devices, such
as an artificial tooth, in
order to restore patient
esthetics and chewing
function. Indicated for
single or multiple unit
restorations in splinted
or non-splinted
applications. May be
placed immediately and
put into immediate
function providing that
the initial stability
requirements detailed in
the surgical manuals are
satisfied. Indicated for
use in soft bone or
whenever immediate or
early loading is applied.
Incorporate a groove on
the implant thread and | For single-stage or
two-stage surgical
procedures and cement
or screw retained
restorations. Intended
for immediate
placement and
function on single
tooth and or multiple
tooth applications
recognizing sufficient
bone stability (type I
or I1 bone) and
appropriate occlusal
loading, to restore
chewing function.
Multiple tooth
applications may be
splinted with a bar. |
| Feature | The Panthera Dental
Milled Bars
(proposed device) | The Panthera Dental
Milled Bars
(Primary Predicate
K173466) | NobelActive
(K071370, K133731),
NobelParallel CC
(K173418) | NobelReplace
(K062566,
K073142, K023113) | NobelSpeedy
(K160119 incl.
K050406) | Brånemark
(K022562) |
| | | | NobelParallel CC: As
endosseous implants
intended to be
surgically placed in the
upper or lower jaw
bone for anchoring or
supporting
replacements to restore
patient esthetics and
chewing function.
Indicated for single or
multiple restorations in
splinted or non-splinted
applications. This can
be achieved by a 2-
stage or 1-stage
surgical techniques in
combination with
immediate, early or
delayed loading
protocols, recognizing
sufficient primary
stability and
appropriate occlusal
loading for the selected
technique. Implants
with (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
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Image /page/11/Picture/0 description: The image shows the 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, purple font, with the word "DENTAL" written in a smaller font below it.
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° 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.
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.
5.5.4 Fatigue Testing
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/12/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 stylized, purple font, and below that, the word "DENTAL" is written in a smaller, sans-serif font.
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 Nobel Biocare 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 Nobel Biocare cylinder's interface connection and to ensure a perfect fit between the proposed cylinder and its Nobel Biocare RE counterparts (implant and screw).
The RE of the Nobel Biocare components gives the assurance that the RE values of the connection interfaces of our proposed device fall within the measured sizes of the Nobel Biocare 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.
5.5.6 Process capability study
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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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.