(531 days)
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.
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.
The provided text describes a medical device, the Proximerge™ 2 Dental Implant System, seeking 510(k) clearance from the FDA. It details device characteristics, comparisons to predicate devices, and performance data from non-clinical testing. However, it does not include acceptance criteria for an AI/ML powered device, nor does it describe a study involving an AI/ML model's performance.
Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria or a study proving an AI device meets them based on the input text. The information requested (acceptance criteria table, sample size, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set size, etc.) is specifically for AI/ML performance evaluation, which is not present in this document about a dental implant system.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------- |
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K211409 - 510(K) SUMMARY
| Submitter's Name: | Quadric BioMed, LLC |
|---|---|
| Submitter's Address: | 640 Southpointe Court #150Colorado Springs, CO 80906 |
| Submitter's Telephone: | 719-270-0755 |
| Contact Person: | Nathan Wright MSEmpirical Testing Corp.719-351-0248nwright@empiricaltech.com |
| 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, LLCProximerge™ 2 DentalImplant System (SubjectDevice) | Bicon Implants with a 2.5mmInternal Connection(K092035) | Bicon 6.0 x 8.0mm DentalImplant System(K972417) | Straumann Dental Implant System(K171784) | Keystone Dental Inc. KeystoneDental XL Dental ImplantSystem (K201334) | Comparison | |
|---|---|---|---|---|---|---|
| Indications for Use: | The Proximerge™ 2 DentalImplant System is designed foruse in edentulous sites in themandible or maxilla as a singletooth replacement. Theseimplants are indicated fordelayed loading. | The Bicon implant is designed foruse in edentulous sites in themandible or maxilla for support ofa complete denture prosthesis, afinal or intermediate abutment forfixed bridgework or for partialdentures, or as a single toothreplacement. | The 6.0 x 8.0mm implant isdesigned for use in edentuloussites in the mandible or maxillafor support of a completedenture prosthesis, a terminal orintermediate abutment for fixedbridgework, partial dentures, ora single tooth replacement. | Straumann® Dental implants areindicated for oral endostealimplantation in the upper and lowerjaw arches and for the functional andaesthetic oral rehabilitation ofedentulous and partially dentatepatients. Straumann® Dental implantsare also indicated for immediate orearly implantation following extractionor loss of natural teeth. Implants can beplaced with immediate function onsingle-tooth and/or multiple-toothapplications when good primarystability is achieved and withappropriate occlusal loading to restorechewing function. The prostheticrestorations used are single crowns,bridges and partial or full dentures,which are connected to the implantsthrough the corresponding components(abutments). | The XL Dental Implant System isintended for implantation in themaxillary or mandibularmolar region where bone exists andthe surgeon has determined that theplacement of a narrower diameterimplant would increase theprobability of failure due to poorprimary stability, or increasedsurgical procedures leading tocomplications. This XL implantsystem provides support for fixed orremovable dental prostheses in asingle tooth, partially edentulousprostheses or full arch prostheses. Itfurther adds the option forimmediate loading on single andsplinted multiple unit restorationswhen good primary stability isachieved and with appropriateocclusal loading, to restore chewingfunction. | Subject indications are similar to theindications of K092035 and K972417.The predicate and reference devicesare for delayed loading as well but didnot specify so in their indications foruse statement. The predicate andreference devices offer additionalapplications such as support fordenture and bridgework prostheses thatthe subject does not seek to indicate.The subject indications are similar tothose of K171784 and K201334 butthose reference devices are intendedfor both immediate and delayedloading and include additionalindications not covered by subject. |
| Product Code: | DZE, NHA | DZE | DZE | DZE | DZE, NHA | Same. The predicate and all referencedevices include abutments but somewere cleared with only the DZEproduct code without the abutmentproduct code NHA. |
| Purpose for being referenced: | This device was made the primarypredicate because of itstechnology for which the subjectis similar in indications, material,press-fit implantation style, somesizes, surface treatment, andabutments. | This device is included as areference device to show thatsubject bone contact surface areais larger than that of a clearedpredicate. | This predicate was included for acomparison of the subject'smechanical performance to that of acleared predicate and for additionalabutment size comparisons. | This predicate has been included sothat the envelope of subject implantfootprints is not outside the range ofcleared and for additional abutmentsize 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 7mmfalls within the envelope of lengths ofcleared predicate implants. |
| Footprint (Elongated):Size 4.5x6.3 mm Implant(24.0mm2 cross-sectional area)Size 4.5x7.6 mm Implant (29.9mm2 cross-sectional area)Size 4.5x9.1 mm Implant (36.6mm2 cross-sectional area)Size 4.5x10.5mm Implant (42.9mm2 cross-sectional area)Note: The subject implantfootprint measurement is thebuccal-lingual width by mesial-distal length. All predicates have | Footprint (Round):Ø4mm (12.6 mm2 cross-sectionalarea)Ø4.5mm (15.9 mm2 cross-sectional area) | Footprint (Round): Ø6mm (28.3mm2 cross-sectional area) | Footprint (Round): 8.6mm2 (Ø3.3mm)to 18.1mm2 (Ø4.8mm) | Footprint (Round): 38.5mm2(Ø7mm), 50.3mm2 (Ø8mm),63.6mm2 (Ø9mm) | The subject implant has an elongatedshape while the predicate implantshave round shapes. This differencedoes not affect the substantialequivalence of the subject devicebecause sufficient residual bone ispresent on all side of the implant.The subject implant footprint cross-sectional area envelope falls within theenvelope of predicate footprint areas.The subject ranges from 24.0mm2 to42.9mm2. Predicate and referenceimplant footprint cross-sectional arearanges from 8.6mm2 to 63.6mm2. | |
| Quadric BioMed, LLCProximerge™ 2 DentalImplant System (SubjectDevice) | Bicon Implants with a 2.5mmInternal Connection(K092035) | Bicon 6.0 x 8.0mm DentalImplant System(K972417) | Straumann Dental Implant System(K171784) | Keystone Dental Inc. KeystoneDental XL Dental ImplantSystem (K201334) | Comparison | |
| a round footprint with thediameter measurement listed. | ||||||
| Implant SurfaceTreatment: | Grit blasted with Hydroxyapatiteand acid etching | Grit blasted with Hydroxyapatiteand acid etching | Grit blasted with Hydroxyapatiteand acid etching | Grit-blasted and acid-etched | Grit blasted and acid etched | Same surface treatment as K092035and K972417. |
| ImplantationMethod: | Press fitting of ridged shaft intothe bone. | Press fitting of ridged shaft intothe bone. | Press fitting of ridged shaft intothe bone. | Driving torque of threaded shaft intothe bone. | Driving torque of threaded shaftinto the bone. | Same method of implantation asK092035 and K972417. |
| Abutment: | Angulation: 0° | Angulation: 0°, 15° | Angulation: 0°, 15° | Angulation: 0°, 15° | Angulation: 0° | The subject abutments angulation iswithin the range of the predicatedevice. |
| Abutment Footprint: Elongatedwith Cross-Sections of 31.2 mm²(for 4.5x6.3 abutment), 44.4mm² (for 4.5x7.6 abutment),55.5 mm² (for 4.5x9.1 abutment,65.8 mm² (for 4.5x10.5abutment) | Abutment Footprint: Round withCross-Section of 12.6 mm²(Ø4mm abutment) and 15.9 mm²(Ø4.5mm abutment) | Abutment Footprint: Round withCross-Section of 8.6 mm² (Ø3.3mmabutment), 13.2 mm² (Ø4.1mmabutment), and 18.1 mm² (Ø4.8mmabutment) | Abutment Footprint: Round withmaximum Cross-Section of 63.6mm² (Ø9mm) | The subject abutment's footprint areaenvelope is within the range of thepredicate and reference devices. Thesubject abutment has a minimumfootprint cross-sectional area of 31.2mm² while the Bicon abutments are assmall as Ø4mm (12.6 mm²). Thesubject abutment has a maximumfootprint cross-section of 65.8 mm²while the Keystone XL abutments areup to 63.6 mm² in cross-section whichis approximately the same. Theelongated footprint of the subjectcompared to the predicate roundfootprint has been justified based onthe implant shape. Mechanical testingshowed that the differences in footprintat the implant-abutment interface doesnot affect the substantial equivalenceof the device. | ||
| Post Height: 4.5mm | Post Height not publicly available | Post Height not publiclyavailable | Post Height not publicly available | Post Height not publicly available | The subject has a post height of4.5mm; a minimum post height of 4mm is typical for FDA clearedabutments. | |
| Gingival Height: 2.4mm | Gingival Height not publiclyavailable | Gingival Height not publiclyavailable | Gingival Height: 1mm – 6mm | Gingival Height 1mm, 3mm | The subject abutment gingival heightfalls within the reference device(K171784 and K201334) envelope ofgingival heights. | |
| Implant Connection: Internaltaper fit (with screw) | Implant Connection: Internal taperfit | Implant Connection: Internaltaper fit (with screw) | Implant Connection: Internal taper fitand internal octagon (with screw) | Implant Connection: Internal taperfit (with Ti-6Al-4V screw) | The subject and the predicate andreference devices have an internaltapered fit implant-abutmentconnection with screw. | |
| Tissue Former (orHealing Abutment): | Collar height of 4.9 with collardiameter/footprint cross-sectionof 31.2 mm², 44.4 mm², 55.5mm², and 65.8 mm². | Sizes not publicly available. | Sizes not publicly available. | Collar height from 1mm to 6mm withcollar cross-section from ≈ 14.2 mm²(3.3x4.3 oval) to 33.2 mm² (Ø6.5mm). | Collar heights of 1mm and 3mmwith collar cross-section from 38.5mm² (Ø7 mm) to 63.6 mm² (Ø9mm). | The subject healing abutments fallsapproximately within the envelope ofreference device (K171784 andK201334) healing abutment collarheights and collar cross-sections. |
| Healing Cap: | Gingival height of 0 mm withdiameter/footprint cross-sectionof 10.6 mm², 17.1 mm², 21.8mm², 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-load bearing component that shieldsthe implant until the permanentabutment is attached. The healing capis 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. | ||||||
| Abutment Surface Treatment: | No surface treatment | No surface treatment. | No surface treatment. | Surface treatment unknown. | Surface treatment unknown. | Same as K092035 and K972417 |
| Implant & Abutment Sterilization: | Provided sterile via EO Sterilization | Sterility unknown. | Sterility unknown. | Provided sterile via Gamma Sterilization | Provided sterile via Gamma Sterilization | The subject and reference devices are provided Sterile to the end user. The identified reference devices are gamma sterilized while the subject is EO sterilized. This difference does not affect the sterility of the device because the sterilization method was validated per ISO 11135 to a sterility assurance level (SAL) of 10-6. |
Quadric BioMed, LLC Proximerge 2 Dental Implant System
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Quadric BioMed, LLC Proximerge 2 Dental Implant System
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Performance Data
The Proximerge™ 2 Dental Implant System has been tested in the following test modes:
- Static axial compression bending ●
- Dynamic axial compression bending per ISO 14801 ●
- SEM EDS Spectroscopy Analysis of surface treatment ●
- . Sterilization validation per ISO 11135
- Bacterial endotoxin testing per ANSI/AAMI ST72
- Packaging stability testing ●
- o Bacterial filtration efficiency per ASTM F2101
- o Blister integrity validation per ASTM F88, F1886, and F1229
- Cytotoxicity testing per ISO 10993-5 ●
- EO Residuals testing per ISO 10993-7 .
The results of this non-clinical testing show that the Proximerge™ 2 Dental Implant System is sufficient for its intended use and is substantially equivalent to the predicate device.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Proximerge™ 2 Dental Implant System is substantially equivalent to the predicate device.
§ 872.3640 Endosseous dental implant.
(a)
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.(b)
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.