(482 days)
No
The document describes a dental implant system and its components. While it mentions using ImageJ for bone level measurements on radiographic images, this is a standard image analysis tool and does not indicate the use of AI or ML for image interpretation or any other function of the device. There are no mentions of AI, ML, or related concepts in the text.
Yes
The device is described as "endosseous dental implants" intended for "oral rehabilitation of edentulous and partially dentate adult patients," which directly relates to treating or restoring a medical condition (edentulism/partial edentulism).
No
Explanation: The device description clearly states that the PiezoImplant System consists of "endosseous dental implants, surgical instruments and restorative components". The intended use is for "dental implant applications for oral rehabilitation". While radiographic images are used for bone level measurements in performance studies, the device itself is for treatment (implantation) and restoration, not for diagnosing conditions.
No
The device description clearly states that the system consists of endosseous dental implants, surgical instruments, and restorative components, which are all hardware. While image processing software (ImageJ) is mentioned for bone level measurements in the performance studies, the core device being cleared is a hardware system.
Based on the provided information, the PiezoImplant System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for dental implant applications for oral rehabilitation. This involves surgically placing a device into the body to restore function and aesthetics.
- Device Description: The device consists of physical components like implants, surgical instruments, and restorative components. These are all physical devices used in a surgical procedure and subsequent restoration.
- Lack of In Vitro Testing: An IVD device is designed to be used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The PiezoImplant System does not perform any such testing.
- Clinical Application: The device is directly implanted into the patient's bone.
While the description mentions using ImageJ for bone level measurements on radiographic images, this is a tool used to analyze images of the implanted device and the surrounding bone in vivo. It's not a diagnostic test performed on a sample in vitro.
Therefore, the PiezoImplant System is a medical device used for surgical and restorative purposes, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
NRO, NHA
Device Description
The PiezoImplant 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 PiezoImplant abutments are offered including Healing, Angled, Straight, Provisional Cylinders and Multi-unit. Restorations can be screw and/or cement-retained to the abutments.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic Images
Anatomical Site
maxilla and mandible
Indicated Patient Age Range
Adult patients over the age of 21.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Two clinical studies were submitted.
Study 1: Case series review of blade-form Rex implants.
Patient Inclusion Criteria: time between loss of dental element and implant placement ≥ 6 months, buccolingual crest thickness ≤ 5 mm, distance between crestal cortex and anatomical limit ≥10 mm, no removable prosthesis in the area of the implant(s).
Sample Size: 56 patients (20 male, 35 female, ages 24 to 81 years, mean age 59.7 years at surgery), received 111 implants. 37 patients (79 implants) met the additional minimum twelve months post-loading criterion.
Data Source: Five OUS clinical centers.
Annotation Protocol: 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.
Key Results:
- Success rate: 88.6% (70/79) implants were a success (optimum health) according to the ICOI Heath Scale after a minimum of one year post-loading.
- Mean (SD) bone level change from implantation (timepoints 34 to 106 months): -0.68 (±1.05) mm (for 37 implants from 20 patients).
- Mean (SD) bone level change post-loading (timepoints 1.3 to 79 months): -0.05 (± 0.55) mm.
- 35/37 implants met the bone loss criteria of ≤1 mm at year one plus 0.2 mm/per year for every year thereafter.
Study 2: Prospective cohort study.
Patient Inclusion Criteria: 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.
Sample Size: 44 patients (15 male, 29 female, mean age 59.5 ± 12 years, age range 35 to 88 years). 59 REX TL implants were implanted. Results pertain to 58 implants (43 patients) after one implant was lost.
Data Source: Six OUS clinical centers (International Piezosurgery Academy Study).
Annotation Protocol: Radiographs were taken at the time of implantation, at loading (6 months post-implantation) and at the 12-month post-loading (18 months post-implantation) timepoints.
Key Results:
- Intraoperative discomfort: None, slight or mild in 42 of 44 patients; 2 patients reported discomfort as severe.
- Mean (SD) VAS for pain the day after surgery: 24 ± 15, reduced to near zero by postoperative day six.
- Mean (SD) marginal bone loss between implantation and time of loading: 0.38 (± 0.48) mm.
- Mean (SD) marginal bone loss between time of loading and 12 months post-loading: 0.20 (± 0.19) mm.
- All 58 implants were satisfactory at one year post-loading.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Biomet 3i T3 (Biomet 3i™, K133049)
Reference Device(s)
Startanius™ NRI (Park Dental Research Corp., K854749), Zimmer Tapered Screw-Vent (Zimmer Dental Inc, K061410), Xive Dental Implant System (FRIADENT GmbH - K032158)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (6/20)
PSC Publishing Services (301) 443-6740 EF
3
510(k) Summary
| Date: | 6 October 2022 | |
|---|---|---|
| Sponsor: | Rex Implants, Inc. | |
| 850 Michigan Avenue | ||
| Columbus, OH 43215 | ||
| Phone 614.459.4922 | ||
| Sponsor Contact: | Giuseppe Vercellotti, PhD, President | |
| 510(k) Contact: | Karen E. Warden, PhD | |
| BackRoads Consulting Inc. | ||
| PO Box 566 | ||
| Chesterland, OH 44026 | ||
| Office: 440.729.8457 | ||
| Trade Name: | Piezolmplant System | |
| Common Name: | Endosseous dental implants and dental abutments | |
| Device Classification | Class II | |
| Regulation Name, | ||
| Regulation, Device | ||
| Product Code: | Endosseous Dental Implant, 872.3640, NRQ | |
| Endosseous Dental Implant Abutment, 872.3630, NHA | ||
| Device Description: | 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. | ||
| Indications for Use: | The Piezolmplant 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 Piezolmplant System is intended for delayed | ||
| loading. | ||
| Materials: | The Piezolmplant System implants, abutments, cover screws and retention | |
| screws are manufactured from titanium alloy (Ti-6AI-4V ELI) as described by | ||
| ASTM 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 provided | ||
| comparative information to support substantial equivalence. | ||
| Zimmer Tapered Screw-Vent (Zimmer Dental Inc, K061410) and | ||
| Xive Dental Implant System (FRIADENT GmbH - K032158) | ||
| Subject Device | Primary Predicate | |
| System: | Piezolmplant System | Biomet 3i |
| 510(k) Number: | K211872 | K133049 |
| The Piezolmplant 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 | ||
| Piezolmplant System is intended | ||
| for delayed loading. | 3i T3® dental implants are | |
| intended for surgical placement in | ||
| the upper or lower jaw to provide a | ||
| means for prosthetic attachment in | ||
| single tooth restorations and in | ||
| partially or fully edentulous spans | ||
| with multiple single teeth utilizing | ||
| delayed or immediate loading, or | ||
| as a terminal or intermediary | ||
| abutment for fixed or removable | ||
| bridgework, and to retain | ||
| overdentures. | ||
| 3i T3® Dental Implants are | ||
| intended for immediate function on | ||
| single tooth and/or multiple tooth | ||
| applications when good primary | ||
| stability is achieved, with | ||
| appropriate occlusal loading, in | ||
| order to restore chewing function. | ||
| Comparison: | The subject device has the same intended use as the primary | |
| predicate device except that the predicate device is additionally | ||
| intended for use in immediate loading situations. The subject device is | ||
| not intended for use in immediate loading situations. However, the | ||
| intended use for the subject device is encompassed by the intended | ||
| use for the predicate device therefore this difference does not affect | ||
| safety or effectiveness. |
4
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 of | |||
| manufacture: | Titanium alloy (ASTM | ||
| F136) | CP Titanium (ASTM | ||
| F67) | Titanium alloy | ||
| (Ti6Al4V) | |||
| Design: | |||
| Endosseous implant | Wedge shaped blade- | ||
| form | Root-form, Straight | ||
| and 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 blasted | ||
| endosseous surface | Yes, apical surface | ||
| RBM blasted + dual | |||
| acid etched | Yes, surface is RBM | ||
| blasted and acid | |||
| etched | |||
| Connection to | |||
| abutment | Hex alignment | ||
| (internal and external), | |||
| screw attachment | Hex alignment, screw | ||
| attachment | Hex alignment, screw | ||
| attachment | |||
| Subject Device | Primary Predicate | Reference Device | |
| System: | PiezlImplant System | Biomet 3i | Startanius™ NRI |
| 510(k) Number: | K211872 | K133049 | K854749 |
| Abutments | |||
| Healing | Healing Abutment TL | ||
| 1.8 & 2.9 | EP® Healing Abutment | ||
| (One Piece) | Standard and Wide | ||
| Healing 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 TL | ||
| 1.8 & 2.9 | Angled GingiHue® | ||
| Post | 25 Degree Angled | ||
| Cementable Abutment | |||
| Surface Treatment | None | Gold-colored titanium | |
| nitride | 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 TL | ||
| 1.8 & 2.9 | Straight GingiHue® | ||
| Post | Hexed Cementable | ||
| Abutment | |||
| 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 Cylinder | ||
| TL 1.8 & 2.9 | Titanium Temporary | ||
| Cylinder | |||
| Surface Treatment | None | Gold-colored titanium | |
| nitride | |||
| 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 TL | ||
| 1.8 & 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 predicate | ||
| but generally the same as the reference device. The dimensional | |||
| features of the subject implant lie within those of either the predicate or | |||
| reference device, e.g., the subject endosseous lengths are shorter than | |||
| the predicate and longer than the reference. The abutment connection | |||
| is the same across both the predicate and reference devices. The | |||
| subject, predicate and reference devices all have modified surfaces, | |||
| though is a slight difference in that the subject implant is not acid | |||
| etched. However, the intent of any modified surface is to improve | |||
| osseointegration therefore the absence of this process is not expected | |||
| to adversely affect the performance of the subject device. In addition, | |||
| clinical data have been submitted which demonstrate the capability for | |||
| osseointegration of the subject implant. Therefore, this difference does | |||
| not 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 the | |||
| subject angled abutment is within that of the predicate reference device | |||
| angled abutment. The material of the subject abutments is the same | |||
| as, or comparable to, that of the predicate and/or reference device | |||
| abutments. Color anodization of the subject healing and straight | |||
| abutments does not affect safety and effectiveness since this is a | |||
| process which does not affect the material substrate but provides the | |||
| perception of color to the human eye. The emergence profile and collar | |||
| height of the subject abutments are within or slightly different than | |||
| those of the predicate and/or reference device abutments. However, | |||
| mechanical testing data have been submitted which demonstrate the | |||
| worst case subject configuration is mechanically sufficient. Therefore, | |||
| these small dimensional differences do not affect safety and | |||
| effectiveness of the subject system. | |||
| Bench Performance | |||
| Data: | Mechanical testing of the worst case Piezolmplant System devices was | ||
| performed according to ISO 14801 and included static and dynamic tests. | |||
| Additionally surface assessments (SEM, EDS and AES) using | |||
| representative samples and corrosion testing per ASTM F2129 and MR | |||
| Compatibility per ASTM F2503 using subject devices were performed. | |||
| Cytotoxicity (per ISO 10993-5) results were submitted to demonstrate | |||
| biocompatibility. | |||
| 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. Sterilization | |||
| validations (per ISO 17665-1/-2) were performed for the non-sterile devices | |||
| The Piezolmplant System devices met the pre-determined acceptance | |||
| criteria for each evaluation and fulfilled the special controls for blade-form | |||
| endosseous dental implants, as defined by 21 CFR 872.3640. | |||
| Clinical Data: | To meet the Class II Special Controls clinical experience requirement, the | ||
| outcomes from two clinical studies was submitted. | |||
| In the first, a case series review of blade-form Rex implants was | |||
| undertaken. To be included in this review a patient had to meet the following | |||
| inclusion criteria: the time between loss of the dental element and implant | |||
| placement must be ≥ 6 months, the buccolingual crest thickness must be ≤ | |||
| 5 mm, distance between crestal cortex and anatomical limit must be ≥10 |
5
6
7
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 one
year post-loading. |
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| Conclusion: | The Piezolmplant System possesses the same intended use as the
predicate device. The data provided, including the clinical performance
data, demonstrate that the differences in technological features do not raise
different questions of safety and effectiveness, and that the subject device
has an equivalent performance to the predicate device. Therefore,
Piezolmplant System is substantially equivalent for its intended use. |