(482 days)
The PiezoImplant System is intended for use in dental implant applications for oral rehabilitation of edentulous and partially dentate adult patients over the age of 21 in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. The prosthetic components are connected to the implants by the corresponding abutments. The PiezoImplant System is intended for delayed loading.
The Piezolmplant System consists of endosseous dental implants, surgical instruments and restorative components in a variety of dimensions to accommodate differing patient anatomy. The Rex TL endosseous implants are blade-form having a wedge shape and an endosseous resorbable blast media (RBM) surface. The REX TL 1.8 implant series has a buccolingual thickness of 1.8mm, a mesiodistal width of 5mm and an external hex connection platform. The REX TL 2.9 implant series has a buccolingual thickness of 2.9mm, a mesiodistal width of 5mm and an internal hex connection platform. The endosseous lengths for both implant series range from 9mm to 15mm and all lengths are offered for both series. Cover screws provide protection to the threads of the abutment connection during endosseous and gingival healing. Retention screws fasten the implant and abutment. A variety of Piezolmplant abutments are offered including Healing, Angled, Straight, Provisional Cylinders and Multi-unit. Restorations can be screw and/or cement-retained to the abutments.
The provided text describes a 510(k) premarket notification for the Rex Implants, Inc. PiezoImplant System. This submission is for a dental implant system, and most of the document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and mechanical testing. The document also includes information about two clinical studies to support the special controls for blade-form endosseous dental implants.
It's important to note that this is NOT a study that "proves the device meets the acceptance criteria" in the typical sense of a clinical trial proving efficacy against pre-defined endpoints for a drug or novel device. Instead, it's a demonstration of substantial equivalence, where the device needs to show similar performance to legally marketed predicate devices, especially regarding safety and effectiveness, to gain market clearance. The acceptance criteria in this context are for substantial equivalence, often demonstrated through comparison to predicates and meeting special controls, which include mechanical testing and, in this case, clinical experience.
Here's a breakdown of the requested information based on the provided text, focusing on the clinical data section which is most relevant to "device performance" in a functional sense:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state "acceptance criteria" for the clinical performance in a structured table. Instead, it refers to fulfilling "special controls" and showing "equivalent performance" to the predicate. The "acceptance criteria" presented below are derived from industry standards and the performance metrics mentioned in the clinical studies.
| Acceptance Criterion (Derived from Special Controls & Clinical Practice) | Reported Device Performance (PiezoImplant System) |
|---|---|
| Study 1: Case Series (Retrospective) | |
| Implant Success Rate (accord. to ICOI Health Scale) at ≥ 1 year post-loading | 88.6% (70/79 implants) deemed a success (optimum health). |
| Bone Loss Criteria (≤1mm at year one + 0.2 mm/year thereafter) | Mean (SD) bone level change following implantation (34 to 106 months): -0.68 (±1.05) mm (for 37 implants across 20 patients).Mean (SD) bone level change post-loading (1.3 to 79 months): -0.05 (± 0.55) mm (for 37 implants across 20 patients).Implants meeting bone loss criteria: 35/37 (All but two implants met the criteria). |
| Study 2: Prospective Cohort Study | |
| Intraoperative Discomfort (VRS) | 42 of 44 patients reported discomfort as none, slight, or mild.2 patients reported discomfort as severe. |
| Postoperative Pain (VAS) | Mean (SD) VAS on day after surgery: 24 ± 15 (max 100-point scale). Reduced to near zero by postoperative day six. |
| Marginal Bone Loss (Implantation to Loading) | 0.38 (± 0.48) mm (mean SD). |
| Marginal Bone Loss (Loading to 12 months post-loading) | 0.20 (± 0.19) mm (mean SD). |
| Implant Satisfaction at 1 year post-loading | All 58 implants (from 43 patients) were satisfactory at one year post-loading. |
2. Sample Size Used for the Test Set and the Data Provenance
-
Study 1 (Case Series Review):
- Initial Patient Sample: 56 patients (20 male, 35 female, ages 24 to 81, mean age 59.7 years).
- Implants: 111 implants.
- Patients meeting ≥12 months post-loading criterion: 37 patients (79 implants).
- Patients with follow-up radiographs: 23 patients (43 implants).
- Patients with time of implantation radiographs: 20 patients (37 implants) for bone level measurements.
- Data Provenance: The text states "Clinical data from five OUS clinical centers was acquired," indicating data from Outside the U.S. and is retrospective.
-
Study 2 (Prospective Cohort Study):
- Initial Patient Sample: 44 patients (15 male, 29 female, mean age 59.5 ± 12 years, age range 35 to 88 years).
- Implants: 59 REX TL implants implanted. One implant was lost, leaving 58 implants (from 43 patients) for analysis.
- Data Provenance: "44 patients... were prospectively enrolled in an International Piezosurgery Academy Study at six OUS clinical centers," indicating data from Outside the U.S. and is prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not specify the number of experts used to establish ground truth or their qualifications for either clinical study.
- For Study 1, it mentions "Bone level measurements were made on each radiographic image using ImageJ." It doesn't state who performed these measurements or if multiple experts were involved in defining the baseline or changes.
- For Study 2, clinical outcomes like discomfort, pain, and marginal bone loss were recorded, but the involvement of independent experts for ground truth establishment beyond the reporting clinicians is not detailed.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the clinical outcomes or ground truth establishment in either study. The results appear to be reported based on direct collection and measurement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a MRMC comparative effectiveness study was not done. The studies described are clinical outcome studies for the device itself, not studies comparing human reader performance with and without AI assistance for interpretation. The device itself is a physical implant, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical dental implant system, not a software algorithm. Therefore, "standalone algorithm performance" is not relevant to this device. The clinical studies assess the physical implant's performance in human patients.
7. The Type of Ground Truth Used
- Study 1 (Case Series):
- Implant Success: Based on the ICOI Health Scale. While this is a clinical scale, it's applied to the clinical observations and outcomes of the implants.
- Bone Level Changes: Radiographic measurements using ImageJ, with the implant shoulder as a reference. This is a form of radiological ground truth based on quantifiable measurements.
- Study 2 (Prospective Cohort):
- Intraoperative Discomfort: Patient-reported (via VRS - likely Verbal Rating Scale). This is patient-reported outcome data.
- Postoperative Pain: Patient-reported (via VAS - Visual Analog Scale). This is patient-reported outcome data.
- Marginal Bone Loss: Radiographic measurements. This is a form of radiological ground truth.
- Implant Satisfaction: Clinical assessment based on the study protocol, leading to the conclusion that "All of the 58 implants were satisfactory." This is likely clinical outcome data based on defined criteria.
8. The Sample Size for the Training Set
Not applicable. The PiezoImplant System is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The "training set" for the development of such a device would involve engineering design, material science research, and mechanical testing, not a dataset in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As explained above, there is no "training set" for this physical device in the AI sense. Ground truth for the development of the device would involve established scientific and engineering principles, material standards (e.g., ASTM F136 for titanium alloy), and mechanical testing methodologies (e.g., ISO 14801). The "ground truth" for the clinical studies mentioned above is established through clinical observation, patient reports, and radiographic measurements as detailed in point 7.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Rex Implants, Inc. % Karen Warden President BackRoads Consulting PO Box 566 Chesterland, Ohio 44026
Re: K211872
Trade/Device Name: PiezoImplant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: NRO. NHA Dated: September 13, 2022 Received: September 14, 2022
Dear Karen Warden:
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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K211872
Device Name
PiezoImplant System
Indications for Use (Describe)
The PiezoImplant System is intended for use in dental implant applications for oral rehabilitation of edentulous and partially dentate adult patients over the age of 21 in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. The prosthetic components are connected to the implants by the corresponding abutments. The PiezoImplant System is intended 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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510(k) Summary
| Date: | 6 October 2022 | |
|---|---|---|
| Sponsor: | Rex Implants, Inc.850 Michigan AvenueColumbus, OH 43215Phone 614.459.4922 | |
| Sponsor Contact: | Giuseppe Vercellotti, PhD, President | |
| 510(k) Contact: | Karen E. Warden, PhDBackRoads Consulting Inc.PO Box 566Chesterland, OH 44026Office: 440.729.8457 | |
| Trade Name: | Piezolmplant System | |
| Common Name: | Endosseous dental implants and dental abutments | |
| Device Classification | Class II | |
| Regulation Name,Regulation, DeviceProduct Code: | Endosseous Dental Implant, 872.3640, NRQEndosseous Dental Implant Abutment, 872.3630, NHA | |
| Device Description: | The Piezolmplant System consists of endosseous dental implants, surgicalinstruments and restorative components in a variety of dimensions toaccommodate differing patient anatomy. The Rex TL endosseous implants areblade-form having a wedge shape and an endosseous resorbable blast media(RBM) surface. The REX TL 1.8 implant series has a buccolingual thicknessof 1.8mm, a mesiodistal width of 5mm and an external hex connectionplatform. The REX TL 2.9 implant series has a buccolingual thickness of2.9mm, a mesiodistal width of 5mm and an internal hex connection platform.The endosseous lengths for both implant series range from 9mm to 15mm andall lengths are offered for both series. Cover screws provide protection to thethreads of the abutment connection during endosseous and gingival healing.Retention screws fasten the implant and abutment. A variety of Piezolmplantabutments are offered including Healing, Angled, Straight, ProvisionalCylinders and Multi-unit. Restorations can be screw and/or cement-retained tothe abutments. | |
| Indications for Use: | The Piezolmplant System is intended for use in dental implant applications fororal rehabilitation of edentulous and partially dentate adult patients over theage of 21 in the maxilla and mandible. Implant retained restorations mayconsist of single crowns or bridges as well as complete or partial dentures.The prosthetic components are connected to the implants by thecorresponding abutments. The Piezolmplant System is intended for delayedloading. | |
| Materials: | The Piezolmplant System implants, abutments, cover screws and retentionscrews are manufactured from titanium alloy (Ti-6AI-4V ELI) as described byASTM F136. | |
| Primary Predicate: | Biomet 3i T3 (Biomet 3i™, K133049) | |
| Reference devices: | Startanius™ NRI (Park Dental Research Corp., K854749).Published clinical results for the following reference devices providedcomparative information to support substantial equivalence.Zimmer Tapered Screw-Vent (Zimmer Dental Inc, K061410) andXive Dental Implant System (FRIADENT GmbH - K032158) | |
| Subject Device | Primary Predicate | |
| System: | Piezolmplant System | Biomet 3i |
| 510(k) Number: | K211872 | K133049 |
| The Piezolmplant System isintended for use in dental implantapplications for oral rehabilitationof edentulous and partially dentateadult patients over the age of 21 inthe maxilla and mandible. Implantretained restorations may consistof single crowns or bridges as wellas complete or partial dentures.The prosthetic components areconnected to the implants by thecorresponding abutments. ThePiezolmplant System is intendedfor delayed loading. | 3i T3® dental implants areintended for surgical placement inthe upper or lower jaw to provide ameans for prosthetic attachment insingle tooth restorations and inpartially or fully edentulous spanswith multiple single teeth utilizingdelayed or immediate loading, oras a terminal or intermediaryabutment for fixed or removablebridgework, and to retainoverdentures.3i T3® Dental Implants areintended for immediate function onsingle tooth and/or multiple toothapplications when good primarystability is achieved, withappropriate occlusal loading, inorder to restore chewing function. | |
| Comparison: | The subject device has the same intended use as the primarypredicate device except that the predicate device is additionallyintended for use in immediate loading situations. The subject device isnot intended for use in immediate loading situations. However, theintended use for the subject device is encompassed by the intendeduse for the predicate device therefore this difference does not affectsafety or effectiveness. |
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Indications for Use:
Technological Characteristics:
| Subject Device | Primary Predicate | Reference Device | |
|---|---|---|---|
| System: | Piezolmplant System | Biomet 3i | Startanius™ NRI |
| 510(k) Number: | K211872 | K133049 | K854749 |
| Material ofmanufacture: | Titanium alloy (ASTMF136) | CP Titanium (ASTMF67) | Titanium alloy(Ti6Al4V) |
| Design: | |||
| Endosseous implant | Wedge shaped blade-form | Root-form, Straightand tapered | Blade-form |
| Method of stabilization | Press-fit +Osseointegration | Threaded fixation | Press-fit +Osseointegration |
| Buccolingual range | 1.8 & 2.9mm | Ø3.25 – 6mm | 1.02 to 3.3mm |
| Width | 5mm | 6.05mm | |
| Endosseous Lengths | 9-15 mm | 6.5 – 18mm | 8 – 14mm |
| Modified surface | Yes, RBM blastedendosseous surface | Yes, apical surfaceRBM blasted + dualacid etched | Yes, surface is RBMblasted and acidetched |
| Connection toabutment | Hex alignment(internal and external),screw attachment | Hex alignment, screwattachment | Hex alignment, screwattachment |
| Subject Device | Primary Predicate | Reference Device | |
| System: | PiezlImplant System | Biomet 3i | Startanius™ NRI |
| 510(k) Number: | K211872 | K133049 | K854749 |
| Abutments | |||
| Healing | Healing Abutment TL1.8 & 2.9 | EP® Healing Abutment(One Piece) | Standard and WideHealing Abutment |
| Surface Treatment | Color Anodized | None | None |
| Emergence Profile Ø | 3.3, 4.5mm | 3.8 - 7.5mm | 4.25 - 5.3 mm |
| Collar Height | 1 - 4mm | 2 - 8mm | 2 - 5mm |
| Angulation | 0° | 0° | 0° |
| Material | ASTM F136 | CP titanium | |
| Angled | Angled Abutment TL1.8 & 2.9 | Angled GingiHue®Post | 25 Degree AngledCementable Abutment |
| Surface Treatment | None | Gold-colored titaniumnitride | None |
| Emergence Profile Ø | 5mm | 3.8 - 6mm | |
| Collar Height | 2mm | 2 - 4mm | |
| Angulation | 15°, 17° | 15° | 25° |
| Material | ASTM F136 | Titanium Alloy | Titanium |
| Straight | Straight Abutment TL1.8 & 2.9 | Straight GingiHue®Post | Hexed CementableAbutment |
| Surface Treatment | Color Anodized | Gold titanium nitride | None |
| Emergence Profile Ø | 5mm | 3.8 - 6mm | |
| Collar Height | 3mm | 2 - 4mm | 2.5mm |
| Angulation | 0° | 0° | 0° |
| Material | ASTM F136 | Titanium Alloy | Titanium, PEEK |
| Cylinder | Provisional CylinderTL 1.8 & 2.9 | Titanium TemporaryCylinder | |
| Surface Treatment | None | Gold-colored titaniumnitride | |
| Emergence Profile Ø | 5mm | ~ 4.1mm | N/A |
| Collar Height | 3mm | N/A | |
| Angulation | 0° | 0° | |
| Material | ASTM F136 | Titanium Alloy | |
| Multi-unit | Multi-unit Abutment TL1.8 & 2.9 | Low Profile Abutment | Multi-Unit Abutment |
| Surface Treatment | None | None | None |
| Emergence Profile Ø | 4.5mm | 4.8mm | |
| Collar Height | 1 - 4mm | 1 - 5mm | 1 - 2.5mm |
| Coping Platform Height | 1.2mm | 2.2mm | |
| Angulation | 0° | 0° - 30° | 0° |
| Material | ASTM F136 | Titanium Alloy | Titanium |
| Subject Device | Primary Predicate | Reference Device | |
| System: | Piezolmplant System | Biomet 3i | Startanius™ NRI |
| 510(k) Number: | K211872 | K133049 | K854749 |
| Implant Comparison: | The overall shape of the subject implant is different from the predicatebut generally the same as the reference device. The dimensionalfeatures of the subject implant lie within those of either the predicate orreference device, e.g., the subject endosseous lengths are shorter thanthe predicate and longer than the reference. The abutment connectionis the same across both the predicate and reference devices. Thesubject, predicate and reference devices all have modified surfaces,though is a slight difference in that the subject implant is not acidetched. However, the intent of any modified surface is to improveosseointegration therefore the absence of this process is not expectedto adversely affect the performance of the subject device. In addition,clinical data have been submitted which demonstrate the capability forosseointegration of the subject implant. Therefore, this difference doesnot affect safety and effectiveness. | ||
| Abutment Comparison: | Each of the subject abutment types is included within either (or both)the predicate or reference device systems. The angulation of thesubject angled abutment is within that of the predicate reference deviceangled abutment. The material of the subject abutments is the sameas, or comparable to, that of the predicate and/or reference deviceabutments. Color anodization of the subject healing and straightabutments does not affect safety and effectiveness since this is aprocess which does not affect the material substrate but provides theperception of color to the human eye. The emergence profile and collarheight of the subject abutments are within or slightly different thanthose of the predicate and/or reference device abutments. However,mechanical testing data have been submitted which demonstrate theworst case subject configuration is mechanically sufficient. Therefore,these small dimensional differences do not affect safety andeffectiveness of the subject system. | ||
| Bench PerformanceData: | Mechanical testing of the worst case Piezolmplant System devices wasperformed according to ISO 14801 and included static and dynamic tests.Additionally surface assessments (SEM, EDS and AES) usingrepresentative samples and corrosion testing per ASTM F2129 and MRCompatibility per ASTM F2503 using subject devices were performed.Cytotoxicity (per ISO 10993-5) results were submitted to demonstratebiocompatibility.Validations including sterilization (per ISO 11137-1/-2), package integrity(per ISO11607), shelf life (per ASTM F1980) and bacterial endotoxin testing(per AAMI ST72) were performed for the sterile devices. Sterilizationvalidations (per ISO 17665-1/-2) were performed for the non-sterile devicesThe Piezolmplant System devices met the pre-determined acceptancecriteria for each evaluation and fulfilled the special controls for blade-formendosseous dental implants, as defined by 21 CFR 872.3640. | ||
| Clinical Data: | To meet the Class II Special Controls clinical experience requirement, theoutcomes from two clinical studies was submitted.In the first, a case series review of blade-form Rex implants wasundertaken. To be included in this review a patient had to meet the followinginclusion criteria: the time between loss of the dental element and implantplacement must be ≥ 6 months, the buccolingual crest thickness must be ≤5 mm, distance between crestal cortex and anatomical limit must be ≥10 |
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mm and there should be no removable prosthesis in the area of the implant(s).
Clinical data from five OUS clinical centers was acquired for 56 patients, 20 male and 35 female, ages 24 to 81 vears having a mean age of 59.7 years at the time of surgery. These patients received 111 implants. Thirty-one patients received a single implant, three patients received more than six implants; one received seven, one received eight and another received twelve (implantation in two stages). Of these original 56 patients, 37 patients (79 implants) met the additional minimum twelve months postloading criterion.
As a case series, the timepoints at which radiographic images were taken were varied. Follow-up radiographs were available for 23 patients (43 implants), of these time of implantation radiographs were available for 20 patients (37 implants). Bone level measurements were made on each radiographic image using ImageJ (Rasband, W.S., ImageJ, U. S. National Institutes of Health, Bethesda, Maryland, USA, https://imagei.nih.gov/ij/. 1997-2018). Images were scaled using the implant dimensions. The implant shoulder was used as the reference across timepoints, bone level changes were assessed using the time of loading as baseline.
Results: Having a minimum of one year post-loading 88.6% (70/79) implants were a success (optimum health) according to the ICOI Heath Scale (Misch CE, Perel ML, Wang H-L, et al.: Implant Success, Survival, and Failure: The International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference. Implant Dentistry. 17 (1):5-15, 2008). The mean (SD) bone level change from the 37 implants (20 patients) following implantation (timepoints ranged from 34 to 106 months) was -0.68 (±1.05) mm. At timepoints which ranged from 1.3 to 79 months post-loading mean (SD) bone level change was -0.05 (± 0.55) mm. All but two of the implants (35/37) met the bone loss criteria of ≤1 mm at year one plus 0.2 mm/per year for every year thereafter (Kline R, Hoar JE, Beck GH, et al. A prospective multicenter clinical investigation of a bone quality-based dental implant system. Implant Dent. 2002;11:224-234).
In the second study, 44 patients (15 male, 29 female, mean age 59.5 ± 12 years, age range 35 to 88 years) were prospectively enrolled in an International Piezosurgery Academy Study at six OUS clinical centers (Vercellotti T, Troiano G, Oreglia F, Lombardi T, Gregorig G, Morella E, Rapani A, Claudio Stacchi C: Wedge-Shaped Implants for Minimally Invasive Treatment of Narrow Ridges: A Multicenter Prospective Cohort Study. J. Clin. Med. 2020, 9(10), 3301; https://doi.org/10.3390/jcm9103301). The inclusion criteria included: Bone height at the implant site of ≥ 10 mm, buccolingual crest thickness between 3.5 and 5 mm as measured 1 mm below the most coronal point of the alveolar crest, a healed bone crest and patient age >18 years. Two patient-centric endpoints were evaluated: intraoperative discomfort by VRS and pain following surgery by VAS. Radiographs were taken at the time of implantation, at loading (6 months post-implantation) and at the 12-month post-loading (18 months postimplantation) timepoints.
Results: Fifty-nine REX TL implants were implanted; 30 patients received a single implant, 13 received two implants and one patient received three implants. One singly implanted implant was lost at 1 month postimplantation: these results pertain to the remaining 58 implants (43 patients). Intraoperative discomfort was reported as none, slight or mild in 42 of 44 patients; 2 patients reported discomfort as severe. On a 100-point scale, the mean (SD) VAS reported for the day after surgery was 24 ± 15 but was reduced to near zero by postoperative day six. The mean (SD) marginal bone loss between implantation and time of loading was 0.38 (± 0.48) mm and between time of loading and 12 months post-loading this
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| value was 0.20 (± 0.19) mm. All of the 58 implants were satisfactory at oneyear post-loading. | |
|---|---|
| Conclusion: | The Piezolmplant System possesses the same intended use as thepredicate device. The data provided, including the clinical performancedata, demonstrate that the differences in technological features do not raisedifferent questions of safety and effectiveness, and that the subject devicehas an equivalent performance to the predicate device. Therefore,Piezolmplant System is substantially equivalent for its intended use. |
§ 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.