Proximerge 2 Dental Implant System

K211409 · Quadric Biomed, LLC · DZE · Oct 19, 2022 · Dental

Device Facts

• Record ID: K211409
• Device Name: Proximerge 2 Dental Implant System
• Applicant: Quadric Biomed, LLC
• Product Code: DZE · Dental
• Decision Date: Oct 19, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Proximerge™ 2 Dental Implant System is designed for use in edentulous sites in the mandible or maxilla as a single tooth replacement. These implants are indicated for delayed loading.

Device Story

Proximerge™ 2 Dental Implant System consists of endosseous dental implants, abutments, temporary abutments, and closure screws. Implants feature elongated mesial-distal footprints (4.5x6.3mm to 4.5x10.5mm) and 7mm length, designed for press-fit installation into bone. Abutments have 0° angulation and tapered implant-abutment interfaces, secured via M1.8 capture screws. Used by dental clinicians in clinical settings for single-tooth restoration. System provides structural support for prosthetic teeth. Benefits include restoration of chewing function in edentulous sites.

Clinical Evidence

Bench testing only. Testing included static and dynamic axial compression bending (ISO 14801), SEM EDS surface analysis, sterilization validation (ISO 11135), bacterial endotoxin testing (ANSI/AAMI ST72), packaging stability (ASTM F2101, F88, F1886, F1229), cytotoxicity (ISO 10993-5), and EO residuals (ISO 10993-7).

Technological Characteristics

Material: Ti-6Al-4V ELI (ASTM F136). Design: Endosseous, press-fit, elongated footprint. Connection: Internal taper fit with M1.8 screw. Surface: Grit-blasted with hydroxyapatite and acid-etched. Sterilization: Ethylene Oxide (EO) to SAL 10^-6.

Indications for Use

Indicated for single tooth replacement in edentulous sites of the mandible or maxilla in adult patients requiring delayed loading.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

• Bicon Implants with a 2.5mm Internal Connection (K092035)

Reference Devices

• 6.0 x 8.0mm Dental Implant System (K972417)
• Straumann Dental Implant System (K171784)
• Keystone Dental XL Dental Implant System (K201334)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Quadric BioMed, LLC % Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K211409

Trade/Device Name: Proximerge™ 2 Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 16, 2022 Received: September 19, 2022

Dear Nathan Wright:

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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542 of the Act); 21 CFR 1000-1050.

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-

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.

510(k) Number (if known) K211409 Device Name

Proximerge™ 2 Dental Implant System Indications for Use (Describe)

The Proximerge™ 2 Dental Implant System is designed for use in edentulous sites in the mandible or maxilla as a single tooth replacement. These implants are indicated for delayed loading.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div> <span> <b> Prescription Use (Part 21 CFR 801 Subpart D) </b> </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|

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# K211409 - 510(K) SUMMARY

| Submitter's Name: | Quadric BioMed, LLC |
|----------------------------|------------------------------------------------------------------------------------------|
| Submitter's Address: | 640 Southpointe Court #150<br>Colorado Springs, CO 80906 |
| Submitter's Telephone: | 719-270-0755 |
| Contact Person: | Nathan Wright MS<br>Empirical Testing Corp.<br>719-351-0248<br>[e-mail] |
| | Image: EMPIRICAL TESTING CORP logo |
| Date Summary was Prepared: | October 19, 2022 |
| Trade or Proprietary Name: | Proximerge™ 2 Dental Implant System |
| Common or Usual Name: | Endosseous dental implant |
| Classification: | Class II per 21 CFR §872.3640 |
| Product Code: | DZE, NHA |
| Classification Panel: | Dental |

## PREDICATE DEVICE INFORMATION

The subject device in this submission is substantially equivalent in indications, intended use, and design principles to the following predicate and reference devices:

| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type |
|-------------|-------------------------------------------------|----------------------|-------------------|
| K092035 | Bicon Implants with a 2.5mm Internal Connection | Bicon, LLC | Primary Predicate |
| K972417 | 6.0 x 8.0mm Dental Implant System | Bicon, Inc. | Reference Device |
| K171784 | Straumann Dental Implant System | Straumann USA, LLC | Reference Device |
| K201334 | Keystone Dental XL Dental Implant System | Keystone Dental Inc. | Reference Device |

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Proximerge 2TM Dental Implant System is an integrated system of endosseous dental implants with corresponding abutments, temporary abutments, and closure screws. The implants are designed with elongation in the mesial-distal dimension. The implants have a 7mm length and a mesial-distal elongated footprint in 4.5x6.3mm, 4.5x7.6mm, 4.5x9.1mm, and 4.5x10.5mm options and are press-fit into the bone. The abutments have a 0° angulation, have post and gingival heights of 4.5mm and 2.4mm respectively for each implant size, and have a tapered implant-abutment interface . Temporary tissue former abutments (also called healing abutments) and healing caps are offered to protect the implant until the abutment is attached; the tissue formers and healing caps have the same angulation and implant-abutment interface as the permanent abutments. An M1.8 capture screw attaches the abutment, the tissue forming abutment, or the healing cap to the implant. All components in the Proximerge™ 2 Dental Implant System are manufactured from Ti-6A1-4V ELI per ASTM F136.

## INDICATIONS FOR USE

The Proximerge™ 2 Dental Implant System is designed for use in edentulous sites in the mandible or maxilla as a single tooth replacement. These implants are indicated for delayed loading.

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## TECHNOLOGICAL CHARACTERISTICS

The subject and predicate devices have similar technological characteristics and the minor differences of safety and effectiveness. The following is a comparison between the subject and predicates:

| | Quadric BioMed, LLC<br>Proximerge™ 2 Dental<br>Implant System (Subject<br>Device) | Bicon Implants with a 2.5mm<br>Internal Connection<br>(K092035) | Bicon 6.0 x 8.0mm Dental<br>Implant System<br>(K972417) | Straumann Dental Implant System<br>(K171784) | Keystone Dental Inc. Keystone<br>Dental XL Dental Implant<br>System (K201334) | Comparison |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The Proximerge™ 2 Dental<br>Implant System is designed for<br>use in edentulous sites in the<br>mandible or maxilla as a single<br>tooth replacement. These<br>implants are indicated for<br>delayed loading. | The Bicon implant is designed for<br>use in edentulous sites in the<br>mandible or maxilla for support of<br>a complete denture prosthesis, a<br>final or intermediate abutment for<br>fixed bridgework or for partial<br>dentures, or as a single tooth<br>replacement. | The 6.0 x 8.0mm implant is<br>designed for use in edentulous<br>sites in the mandible or maxilla<br>for support of a complete<br>denture prosthesis, a terminal or<br>intermediate abutment for fixed<br>bridgework, partial dentures, or<br>a single tooth replacement. | Straumann® Dental implants are<br>indicated for oral endosteal<br>implantation in the upper and lower<br>jaw arches and for the functional and<br>aesthetic oral rehabilitation of<br>edentulous and partially dentate<br>patients. Straumann® Dental implants<br>are also indicated for immediate or<br>early implantation following extraction<br>or loss of natural teeth. Implants can be<br>placed with immediate function on<br>single-tooth and/or multiple-tooth<br>applications when good primary<br>stability is achieved and with<br>appropriate occlusal loading to restore<br>chewing function. The prosthetic<br>restorations used are single crowns,<br>bridges and partial or full dentures,<br>which are connected to the implants<br>through the corresponding components<br>(abutments). | The XL Dental Implant System is<br>intended for implantation in the<br>maxillary or mandibular<br>molar region where bone exists and<br>the surgeon has determined that the<br>placement of a narrower diameter<br>implant would increase the<br>probability of failure due to poor<br>primary stability, or increased<br>surgical procedures leading to<br>complications. This XL implant<br>system provides support for fixed or<br>removable dental prostheses in a<br>single tooth, partially edentulous<br>prostheses or full arch prostheses. It<br>further adds the option for<br>immediate loading on single and<br>splinted multiple unit restorations<br>when good primary stability is<br>achieved and with appropriate<br>occlusal loading, to restore chewing<br>function. | Subject indications are similar to the<br>indications of K092035 and K972417.<br>The predicate and reference devices<br>are for delayed loading as well but did<br>not specify so in their indications for<br>use statement. The predicate and<br>reference devices offer additional<br>applications such as support for<br>denture and bridgework prostheses that<br>the subject does not seek to indicate.<br>The subject indications are similar to<br>those of K171784 and K201334 but<br>those reference devices are intended<br>for both immediate and delayed<br>loading and include additional<br>indications not covered by subject. |
| Product Code: | DZE, NHA | DZE | DZE | DZE | DZE, NHA | Same. The predicate and all reference<br>devices include abutments but some<br>were cleared with only the DZE<br>product code without the abutment<br>product code NHA. |
| Purpose for being referenced: | | This device was made the primary<br>predicate because of its<br>technology for which the subject<br>is similar in indications, material,<br>press-fit implantation style, some<br>sizes, surface treatment, and<br>abutments. | This device is included as a<br>reference device to show that<br>subject bone contact surface area<br>is larger than that of a cleared<br>predicate. | This predicate was included for a<br>comparison of the subject's<br>mechanical performance to that of a<br>cleared predicate and for additional<br>abutment size comparisons. | This predicate has been included so<br>that the envelope of subject implant<br>footprints is not outside the range of<br>cleared and for additional abutment<br>size comparisons. | |
| Materials: | Ti-6Al-4V ELI per ASTM F136 | Ti-6Al-4V or CP Titanium | CP Titanium | CP Titanium, titanium-zirconium alloy | Titanium Alloy per ASTM F136 | Same as K201334. |
| Implant Sizes: | Length: 7mm | Length: 5, 6, 8, 11mm | Length: 8mm | Length: 6mm to 18mm | Length: 7mm, 9mm, 11mm | The subject implant length of 7mm<br>falls within the envelope of lengths of<br>cleared predicate implants. |
| | Footprint (Elongated):<br>Size 4.5x6.3 mm Implant<br>(24.0mm2 cross-sectional area)<br>Size 4.5x7.6 mm Implant (29.9<br>mm2 cross-sectional area)<br>Size 4.5x9.1 mm Implant (36.6<br>mm2 cross-sectional area)<br>Size 4.5x10.5mm Implant (42.9<br>mm2 cross-sectional area)<br>Note: The subject implant<br>footprint measurement is the<br>buccal-lingual width by mesial-<br>distal length. All predicates have | Footprint (Round):<br>Ø4mm (12.6 mm2 cross-sectional<br>area)<br>Ø4.5mm (15.9 mm2 cross-<br>sectional area) | Footprint (Round): Ø6mm (28.3<br>mm2 cross-sectional area) | Footprint (Round): 8.6mm2 (Ø3.3mm)<br>to 18.1mm2 (Ø4.8mm) | Footprint (Round): 38.5mm2<br>(Ø7mm), 50.3mm2 (Ø8mm),<br>63.6mm2 (Ø9mm) | The subject implant has an elongated<br>shape while the predicate implants<br>have round shapes. This difference<br>does not affect the substantial<br>equivalence of the subject device<br>because sufficient residual bone is<br>present on all side of the implant.<br>The subject implant footprint cross-<br>sectional area envelope falls within the<br>envelope of predicate footprint areas.<br>The subject ranges from 24.0mm2 to<br>42.9mm2. Predicate and reference<br>implant footprint cross-sectional area<br>ranges from 8.6mm2 to 63.6mm2. |
| | Quadric BioMed, LLC<br>Proximerge™ 2 Dental<br>Implant System (Subject<br>Device) | Bicon Implants with a 2.5mm<br>Internal Connection<br>(K092035) | Bicon 6.0 x 8.0mm Dental<br>Implant System<br>(K972417) | Straumann Dental Implant System<br>(K171784) | Keystone Dental Inc. Keystone<br>Dental XL Dental Implant<br>System (K201334) | Comparison |
| | a round footprint with the<br>diameter measurement listed. | | | | | |
| Implant Surface<br>Treatment: | Grit blasted with Hydroxyapatite<br>and acid etching | Grit blasted with Hydroxyapatite<br>and acid etching | Grit blasted with Hydroxyapatite<br>and acid etching | Grit-blasted and acid-etched | Grit blasted and acid etched | Same surface treatment as K092035<br>and K972417. |
| Implantation<br>Method: | Press fitting of ridged shaft into<br>the bone. | Press fitting of ridged shaft into<br>the bone. | Press fitting of ridged shaft into<br>the bone. | Driving torque of threaded shaft into<br>the bone. | Driving torque of threaded shaft<br>into the bone. | Same method of implantation as<br>K092035 and K972417. |
| Abutment: | Angulation: 0° | Angulation: 0°, 15° | Angulation: 0°, 15° | Angulation: 0°, 15° | Angulation: 0° | The subject abutments angulation is<br>within the range of the predicate<br>device. |
| | Abutment Footprint: Elongated<br>with Cross-Sections of 31.2 mm²<br>(for 4.5x6.3 abutment), 44.4<br>mm² (for 4.5x7.6 abutment),<br>55.5 mm² (for 4.5x9.1 abutment,<br>65.8 mm² (for 4.5x10.5<br>abutment) | Abutment Footprint: Round with<br>Cross-Section of 12.6 mm²<br>(Ø4mm abutment) and 15.9 mm²<br>(Ø4.5mm abutment) | | Abutment Footprint: Round with<br>Cross-Section of 8.6 mm² (Ø3.3mm<br>abutment), 13.2 mm² (Ø4.1mm<br>abutment), and 18.1 mm² (Ø4.8mm<br>abutment) | Abutment Footprint: Round with<br>maximum Cross-Section of 63.6<br>mm² (Ø9mm) | The subject abutment's footprint area<br>envelope is within the range of the<br>predicate and reference devices. The<br>subject abutment has a minimum<br>footprint cross-sectional area of 31.2<br>mm² while the Bicon abutments are as<br>small as Ø4mm (12.6 mm²). The<br>subject abutment has a maximum<br>footprint cross-section of 65.8 mm²<br>while the Keystone XL abutments are<br>up to 63.6 mm² in cross-section which<br>is approximately the same. The<br>elongated footprint of the subject<br>compared to the predicate round<br>footprint has been justified based on<br>the implant shape. Mechanical testing<br>showed that the differences in footprint<br>at the implant-abutment interface does<br>not affect the substantial equivalence<br>of the device. |
| | Post Height: 4.5mm | Post Height not publicly available | Post Height not publicly<br>available | Post Height not publicly available | Post Height not publicly available | The subject has a post height of<br>4.5mm; a minimum post height of 4<br>mm is typical for FDA cleared<br>abutments. |
| | Gingival Height: 2.4mm | Gingival Height not publicly<br>available | Gingival Height not publicly<br>available | Gingival Height: 1mm – 6mm | Gingival Height 1mm, 3mm | The subject abutment gingival height<br>falls within the reference device<br>(K171784 and K201334) envelope of<br>gingival heights. |
| | Implant Connection: Internal<br>taper fit (with screw) | Implant Connection: Internal taper<br>fit | Implant Connection: Internal<br>taper fit (with screw) | Implant Connection: Internal taper fit<br>and internal octagon (with screw) | Implant Connection: Internal taper<br>fit (with Ti-6Al-4V screw) | The subject and the predicate and<br>reference devices have an internal<br>tapered fit implant-abutment<br>connection with screw. |
| Tissue Former (or<br>Healing Abutment): | Collar height of 4.9 with collar<br>diameter/footprint cross-section<br>of 31.2 mm², 44.4 mm², 55.5<br>mm², and 65.8 mm². | Sizes not publicly available. | Sizes not publicly available. | Collar height from 1mm to 6mm with<br>collar cross-section from ≈ 14.2 mm²<br>(3.3x4.3 oval) to 33.2 mm² (Ø6.5mm). | Collar heights of 1mm and 3mm<br>with collar cross-section from 38.5<br>mm² (Ø7 mm) to 63.6 mm² (Ø9<br>mm). | The subject healing abutments falls<br>approximately within the envelope of<br>reference device (K171784 and<br>K201334) healing abutment collar<br>heights and collar cross-sections. |
| Healing Cap: | Gingival height of 0 mm with<br>diameter/footprint cross-section<br>of 10.6 mm², 17.1 mm², 21.8<br>mm², and 26.1 mm². | Sizes not publicly available. | Sizes not publicly available. | Sizes not publicly available. | Sizes not publicly available. | The healing cap is a temporary non-<br>load bearing component that shields<br>the implant until the permanent<br>abutment is attached. The healing cap<br>is designed uniquely to the subject |
| | Quadric BioMed, LLC Proximerge™ 2 Dental Implant System (Subject Device) | Bicon Implants with a 2.5mm Internal Connection (K092035) | Bicon 6.0 x 8.0mm Dental Implant System (K972417) | Straumann Dental Implant System (K171784) | Keystone Dental Inc. Keystone Dental XL Dental Implant System (K201334) | Comparison |
| | | | | | | implant geometry. Difference in geometry relative to the predicate and reference devices do not affect the performance of the subject system.…