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

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Panthera Dental Milled Bars, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present acceptance criteria in a tabular format with specific numerical targets. Instead, it describes performance through compliance with recognized standards and successful testing outcomes. The "performance" is primarily demonstrated through meeting mechanical strength requirements and biocompatibility standards, and by showing substantial equivalence to a predicate device.

Acceptance Criteria Category	Description of Criteria (Implied)	Reported Device Performance
Mechanical Strength	Meets the requirements for dynamic fatigue testing for endosseous dental implants.	The device (bar and cylinders) has the mechanical strength for its intended clinical application, as demonstrated by fatigue testing according to ISO 14801 and FDA guidance.
Biocompatibility	Biocompatible with tissue/bone/dentin for long-term contact.	Made from Titanium Ti-6Al-4V, a material used in the predicate. Cytotoxicity, extractable/leachable, toxicological risk assessment, and bacterial endotoxin testing compliant with ISO 10993-1, ISO 10993-5, ISO 10993-12, ANSI/AAMI ST72, and USP <85>.
Sterilization	Can be effectively sterilized to a Sterility Assurance Level (SAL) of 10^-6.	Sterilization validation (Pre-vacuum steam sterilization) for the primary predicate was successful, demonstrating an SAL of at least 10^-6. The proposed device uses the same materials and sterilization cycle, therefore no additional testing was required.
Design Accuracy/Fit	Ensures a perfect fit and proper seating with compatible implant systems, with no possible interference.	Reverse engineering (RE) confirmed that the critical parameters of the design for interface connection, including tolerance limits, fall within the measured sizes of the Nobel Biocare counterparts.
Manufacturing Reliability	Manufacturing process is reliable and produces consistent results.	A process capability study conducted for the primary predicate (K173466) is valid for the proposed device, as the manufacturing process is identical.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify the exact sample size for each test (e.g., how many bars were subjected to fatigue testing). It refers to "the bar itself" and "the bar cylinders" for fatigue testing. For reverse engineering, it mentions "each interface connection" and "each components per size and type" which implies multiple samples were analyzed to determine critical parameters and tolerance limits.
Data Provenance: The document does not specify country of origin for data. The non-clinical testing was conducted by Panthera Dental Inc., a Canadian company. The tests are framed within the context of a 510(k) submission to the U.S. FDA. The testing conducted was for the primary predicate device (K173466) and determined to be applicable to the proposed device due to identical materials and manufacturing processes. The tests were retrospective in the sense that they were done on manufactured devices/components.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: This information is not explicitly stated. The document refers to compliance with ISO and FDA guidance documents for testing, which implies a standard methodology rather than expert consensus on a subjective test set.
Qualifications of Experts: Not specified. Testing was performed by Panthera Dental Inc. or their designated testing facilities to meet recognized standards.

4. Adjudication Method for the Test Set

Not applicable. The tests mentioned (fatigue, biocompatibility, sterilization, reverse engineering, process capability) are objective physical, chemical, and mechanical tests, not subjective evaluations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The Panthera Dental Milled Bars are a physical dental device, not an AI or imaging diagnostic tool that would typically involve a reader study.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical medical device, not an algorithm or software. The mention of CAD/CAM refers to the design and manufacturing process, not an independent algorithm performance.

7. Type of Ground Truth Used

The "ground truth" for the device's performance is established through:

Compliance with recognized standards: ISO 14801 for fatigue testing, ISO 10993 series and USP <85> for biocompatibility, and ANSI/AAMI-ST8 for sterilization.
Measurement and verification: Reverse engineering to ensure precise fit with implant systems.
Predicate device equivalence: Performance data for the predicate device (K173466) is directly applied due to identical materials, design principles, and manufacturing processes.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning or AI. The design and manufacturing processes are established based on engineering principles and validated through testing.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" in the context of this device. The design specifications and manufacturing parameters are established through engineering design, material science, and testing against industry standards, not via a machine learning training process.

Summary

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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.

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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

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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-SimonsQuebec City (QC) G2B 0S6Canada
Official Contact:	Martine FortinDirector Regulatory Affairs and Quality Assuranceregulatory@pantheradental.comTel: +1 (418) 527-0388Fax: +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 NobelActiveK173418 NobelParallel Conical ConnectionK062566, K073142, K023113 NobelReplaceK050406, K160119 NobelSpeedy

5.1 Description

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 BetweenCylinders	0°	30°

Table 5.1: Design Specifications of Panthera Dental Bars

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 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.

K192108

Table 5.2: Comparison chart between the proposed device and the reference devices

Feature	The Panthera DentalMilled Bars(proposed device)	The Panthera DentalMilled Bars(Primary PredicateK173466)	NobelActive(K071370, K133731),NobelParallel CC(K173418)	NobelReplace(K062566,K073142, K023113)	NobelSpeedy(K160119 incl.K050406)	Brånemark(K022562)
Regulationdescription	Endosseous dentalimplant abutment	Endosseous dentalimplant abutment	Endosseous dentalimplant	Endosseous dentalimplant	Endosseous dentalimplant	Endosseous dentalimplant
Indicationsfor Use	As an accessory to anendosseous dentalimplant to support aprosthetic device in apartially or edentulouspatient. It is intended foruse to support multipletooth prostheses in themandible or maxilla.The prostheses can bescrew retained.Compatibility with theNobel Biocare systems.	As an accessory to anendosseous dentalimplant to support aprosthetic device in apartially or edentulouspatient. It is intended foruse to support multipletooth prostheses in themandible or maxilla.The prostheses can bescrew retained.Compatibility with theZimmer tapered screw-vent system	NobelActive: Asendosseous implantintended to be surgicallyplaced in the bone of theupper or lower jawarches to providesupport for prostheticdevices, such as anartificial tooth, in orderto restore patientesthetics and chewingfunction. Indicated forsingle or multiple unitrestorations in splintedor non-splintedapplications. May beplaced immediately andput into immediatefunction provided thatinitial stabilityrequirements detailed inthe manual are satisfied.	As endosseous dentalimplants intended tobe surgically placed inthe bone of the upperor lower jaw arches toprovide support forprosthetic devices,such as an artificialtooth, in order torestore patientesthetics and chewingfunction. Indicated forsingle or multiple unitrestorations. Can beused in splinted ornonsplintedapplications. May beplaced immediatelyand put into immediatefunction provided thatinitial stabilityrequirements detailedin the manual aresatisfied.	K050406: Intended tobe surgically placed inthe bone of the upper orlower jaw arches toprovide support forprosthetic devices, suchas an artificial tooth, inorder to restore patientesthetics and chewingfunction. Indicated forsingle or multiple unitrestorations in splintedor non-splintedapplications. May beplaced immediately andput into immediatefunction providing thatthe initial stabilityrequirements detailed inthe surgical manuals aresatisfied. Indicated foruse in soft bone orwhenever immediate orearly loading is applied.Incorporate a groove onthe implant thread and	For single-stage ortwo-stage surgicalprocedures and cementor screw retainedrestorations. Intendedfor immediateplacement andfunction on singletooth and or multipletooth applicationsrecognizing sufficientbone stability (type Ior I1 bone) andappropriate occlusalloading, to restorechewing function.Multiple toothapplications may besplinted with a bar.
Feature	The Panthera DentalMilled Bars(proposed device)	The Panthera DentalMilled Bars(Primary PredicateK173466)	NobelActive(K071370, K133731),NobelParallel CC(K173418)	NobelReplace(K062566,K073142, K023113)	NobelSpeedy(K160119 incl.K050406)	Brånemark(K022562)
			NobelParallel CC: Asendosseous implantsintended to besurgically placed in theupper or lower jawbone for anchoring orsupportingreplacements to restorepatient esthetics andchewing function.Indicated for single ormultiple restorations insplinted or non-splintedapplications. This canbe achieved by a 2-stage or 1-stagesurgical techniques incombination withimmediate, early ordelayed loadingprotocols, recognizingsufficient primarystability andappropriate occlusalloading for the selectedtechnique. Implantswith <7mm length arefor delayed loadingonly when appropriate	Addition forK050258: Groovyimplants are indicatedfor use in soft bone inposterior regions orwhenever immediateor early loading isapplied. The Groovyimplants incorporate agroove on the implantthread and arepreferred over modelswithout the groove inthese soft boneindications becausebone forms morerapidly in thegroove than on otherparts of the implantresulting in increasedstability whencompared to non-grooved implants.Addition forK023113: If the singlestage procedure isused, these implantsmay be loadedimmediately followinginsertion provided at	are preferred overmodels without thegroove in these soft boneindications because boneforms more rapidly inthe groove than on otherparts of the implantresulting in increasedstability when comparedto non-groovedimplants. In addition,preferred in these softbone indications becausebone formation on theTi~lnite surface is morerapid and greater than onmachined surfaceimplants resulting inbetter maintenance ofinitial implant stability,faster and strongerosseointegration, andhigher success rates.Implants may be tiltedup to 45°. When usedwith angulationsbetween 30° and 45° aminimum of fourimplants must be usedand splinted.
Feature	The Panthera DentalMilled Bars(proposed device)	The Panthera DentalMilled Bars(Primary PredicateK173466)	NobelActive(K071370, K133731),NobelParallel CC(K173418)	NobelReplace(K062566,K073142, K023113)	NobelSpeedy(K160119 incl.K050406)	Brånemark(K022562)
			stability has beenachieved.	least four implants areplaced, and aresplinted with a bar.These implants mustbe placedpredominantly in theanterior mandible(between the mentalforamina) where goodinitial stability of theimplants, with orwithout bi-corticalanchorage, can mostoften be obtained.	K160119: Intended to besurgically placed in theupper or lower jaw bonefor anchoring orsupporting toothreplacements to restorepatient esthetics andchewing function.Indicated for single ormultiple unit restorationsin splinted or non-splinted applications.This can be achieved bya 2-stage or 1-stagesurgical technique incombination withimmediate, early ordelayed loadingprotocols, recognizingsufficient primarystability and appropriateocclusal loading for theselected technique.Implants allow also forbicortical anchorage incases of reduced bonedensity. Implants 20, 22,25 mm when placed inthe maxilla are only ind-icated for multiple unitrestorations in splin-ted
Feature	The Panthera DentalMilled Bars(proposed device)	The Panthera DentalMilled Bars(Primary PredicateK173466)	NobelActive(K071370, K133731),NobelParallel CC(K173418)	NobelReplace(K062566,K073142, K023113)	NobelSpeedy(K160119 incl.K050406)	Brånemark(K022562)
					applications that utilizeat least two implants.
DeviceMaterial	Titanium alloy Ti-6Al-4V	Titanium alloy Ti-6Al-4V	CP Titanium	CP Titanium	CP Titanium	CP Titanium
Design/Technology	CAD/CAM milling fromsingle milling blanks.	CAD/CAM milling fromsingle milling blanks.	N/A	N/A	N/A	N/A
ConnectionType	Internal conical,Internal Hex, ExternalHex, Internal Tri-channel	N/A	Internal conical(previously calledInternal Hex)	Internal HexInternal Tri-channel	External Hex	External Hex
ImplantPlatform /diameter(mm)	NobelActive:NP Ø3.5; RP Ø4.3 /Ø5.0; WP Ø5.5NobelParallel CC:NP Ø3.75; RP Ø4.3 /Ø5.0; WP Ø5.5NobelReplaceNP Ø3.5; RP Ø4.0 /Ø4.3 / Ø5.0; WP Ø5.0; 6Ø6.0NobelSpeedy:RP Ø4.0 / Ø5.0; WPØ5.0 / Ø6.0Brånemark:NP Ø3.3; RP Ø3.75 /Ø4.0; WP Ø5.0	Zimmer implant systems	NobelActive:NP Ø3.5; RP Ø4.3 /Ø5.0; WP Ø5.5NobelParallel CC:NP Ø3.75; RP Ø4.3 /Ø5.0; WP Ø5.5	NobelReplaceTapered:NP Ø3.5; RP Ø4.3 /Ø5.0; WP Ø5.0;6 Ø6.0NobelReplaceNP Ø3.5; RP Ø4.0	NobelSpeedy:NP Ø3.5; RP Ø4.0 /Ø5.0; WP Ø5.0 / Ø6.0	Brånemark:NP Ø3.3; RP Ø3.75 /Ø4.0; WP Ø5.0

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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, 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 text is purple.

K192108

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Image /page/8/Picture/0 description: The image shows a logo for Panthera Dental. The logo features a black silhouette of a panther in a crouching position, with its tail curved upwards. Below the panther, the word "PANTHERA" is written in a bold, sans-serif font, with the word "DENTAL" written in a smaller font size below it. The text is purple.

K192108

Confidential

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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" in purple. The word "PANTHERA" is in a larger font than the word "DENTAL".

K192108

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Image /page/10/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 pose. Below the panther image, the word "PANTHERA" is written in a stylized, purple font. Underneath "PANTHERA", the word "DENTAL" is written in a smaller, simpler font, also in purple.

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.

5.5 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<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

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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 <85>. 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.

Regulation Number and Section

§ 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.)