(354 days)
No
The 510(k) summary describes a physical dental implant system and its components, materials, and testing. There is no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML.
Yes.
The device is indicated for use in patients to support dental restorations, which is a therapeutic purpose.
No
Explanation: This device, Reflect™ Dental Implants, is an implantable medical device used for supporting dental restorations in edentulous patients. It is not described as performing any diagnostic function of detecting or assessing a medical condition.
No
The device description clearly indicates that the device is a physical dental implant system made of titanium, including implants, cover screws, healing abutments, and 30° abutments. It describes the physical characteristics, materials, and manufacturing processes of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Reflect™ Dental Implants are used to support dental restorations in patients. This is a direct therapeutic and restorative application within the body.
- Device Description: The description details the physical characteristics, materials, and components of dental implants and abutments, which are surgically implanted devices.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Performance Studies: The performance studies focus on mechanical testing, sterilization, biocompatibility, and engineering analysis, which are typical for implantable medical devices, not IVDs.
IVD devices are designed to perform tests on samples like blood, urine, or tissue to diagnose diseases or conditions. The Reflect™ Dental Implant system is a physical implant used for structural support in dental restorations.
N/A
Intended Use / Indications for Use
Reflect™ Dental Implants are indicated for use in partially or fully edentulous patients to support maxillary and mandibular single-unit, multiple-unit, and overdenture dental restorations. Reflect™ Dental Implants are indicated loading when good primary stability is achieved and with appropriate occlusal loading.
Reflect™ Implant System prosthetic components are compatible with the following implant systems.
| Implant System Compatibility | Implant Body Diameter (mm) | Platform Diameter (mm) |
|---|---|---|
| OsseoSpeed™ | 3.5 | 3.5/4.0 |
| 4.0 | 3.5/4.0 | |
| 5.0 | 4.5/5.0 | |
| 3i Certain® | 3.25 | 3.4 |
| 4.0 | 4.1 | |
| 5.0 | 5.0 | |
| NobelActive® | 3.5 | NP |
| 4.3 | RP | |
| 5.0 | RP | |
| NobelReplace Conical | 3.5 | NP |
| 4.3 | RP | |
| 5.0 | RP | |
| Tapered Screw-Vent® | 3.7 | 3.5 |
| 4.1 | 3.5 | |
| 4.7 | 4.5 |
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
Reflect™ Implant System implants are root form endosseous dental implants with a tapered body and a grit blasted and acid etched surface intended for bone level placement. The subject device consists of five product lines (Reflect™ Aspire, Reflect™ Certus, Reflect™ Rapid, Reflect™ Recover, and Reflect™ Tapered) and three component designs (Cover Screw, Healing Abutment, and 30° Abutment). The Reflect™ implant sizes are summarized in the following table.
| Reflect™ Implant System | |||
|---|---|---|---|
| Implant Line | Body Ø (mm) | Platform Ø (mm) | Implant Lengths (mm) |
| Aspire | 3.5 | 3.5 | 8, 9, 11, 13, 15 |
| 4.0 | 4.0 | 8, 9, 11, 13, 15 | |
| 5.0 | 5.0 | 9, 11, 13, 15 | |
| Certus | 3.3 | 3.4 | 8.5, 10, 11.5, 13, 15 |
| 4.0 | 4.1 | 8.5, 10, 11.5, 13, 15 | |
| 4.9 | 5.0 | 8.5, 10, 11.5, 13, 15 | |
| Rapid | 3.5 | NP | 8.5, 10, 11.5, 13, 15 |
| 4.3 | RP | 8.5, 10, 11.5, 13, 15 | |
| 5.0 | RP | 8.5, 10, 11.5, 13, 15 | |
| Recover | 3.5 | NP | 8.5, 10, 11.5, 13, 16 |
| 4.3 | RP | 8.5, 10, 11.5, 13, 16 | |
| 5.0 | RP | 8.5, 10, 11.5, 13, 16 | |
| Tapered | 3.7 | 3.5 | 8.5, 10, 11.5, 13, 16 |
| 4.1 | 3.5 | 8.5, 10, 11.5, 13, 16 | |
| 4.7 | 4.5 | 8.5, 10, 11.5, 13, 16 |
| Reflect™ Implant System - Abutments | Compatible Implants | |||
|---|---|---|---|---|
| Implant Line | Abutments | Abutment Platform Ø (mm) | Implant System Compatibility | Platform Diameters (mm) |
| Aspire | Aspire Cover Screw | 3.5, 4.0, 5.0 | OsseoSpeed™ | 3.5/4.0, 4.5/5.0 |
| Aspire Ø 3.5/4.0 mm Healing Abutment | 3.5, 4.0 | OsseoSpeed™ | 3.5/4.0 | |
| Aspire Ø 4.5/5.0 mm Healing Abutment | 5.0 | OsseoSpeed™ | 4.5/5.0 | |
| Aspire 30° Abutment | 3.5, 4.0, 5.0 | OsseoSpeed™ | 3.5/4.0, 4.5/5.0 | |
| Certus | Certus Cover Screw 3.4/4.1 mm | 3.4, 4.1 | 3i Certain® | 3.4, 4.1 |
| Certus Cover Screw 5.0 mm | 5.0 | 3i Certain® | 5.0 | |
| Certus Healing Abutment | 3.4, 4.1, 5.0 | 3i Certain® | 3.4, 4.1, 5.0 | |
| Certus 30° Abutment | 3.4, 4.1, 5.0 | 3i Certain® | 3.4, 4.1, 5.0 | |
| Rapid | Rapid Cover Screw | NP, RP | NobelActive® | NP, RP |
| Recover/Rapid Healing Abutment | NP, RP | NobelActive® | NP, RP | |
| Rapid 30° Abutment | NP, RP | NobelActive® | NP, RP | |
| Recover | Recover Cover Screw | NP, RP | NobelReplace Conical | NP, RP |
| Recover/Rapid Healing Abutment | NP, RP | NobelReplace Conical | NP, RP | |
| Recover 30° Abutment | NP, RP | NobelReplace Conical | NP, RP | |
| Tapered | Tapered Cover Screw | 3.5, 4.5 | Tapered Screw-Vent® | 3.5, 4.5 |
| Tapered Healing Abutment | 3.5, 4.5 | Tapered Screw-Vent® | 3.5, 4.5 | |
| Tapered 30° Abutment | 3.5, 4.5 | Tapered Screw-Vent® | 3.5, 4.5 |
The Reflect™ abutment sizes are summarized in the following table. Note: each abutment is provided in each platform diameter listed.
Subject device implants are made of unalloyed titanium conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50400, UNS R50550, UNS R50700) Grade 4, and subject device abutments are made of titanium alloy conforming to ASTM F 136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
The subject device implant surface is produced by blasting with alumina (Al2O3) powder, and etching with hydrochloric acid and sulfuric acid. After etching, the remaining acid is removed by washing with distilled water, followed by cleaning with an alkaline solution using a high temperature and high-pressure hydrothermal method.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and mandibular
Indicated Patient Age Range
Not Found
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)
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: sterilization validation according to ISO 11137-1, ISO 11137-2, ISO 17665-1, and 17665-2; biocompatibility according to ISO 10993-1, 10993-5, and 10993-12; dynamic compression-bending testing according to ISO 14801; and engineering and dimensional analysis of the OEM implant bodies, OEM abutments, and OEM fixation screws. No clinical data were included in this submission.
For components provided sterile (implants, cover screws, and healing abutments) bacterial endotoxin testing was performed according to ANSI/AAMI ST72. Sterile barrier shelf testing was performed according to ASTM standards F88. F1140. F2096, F1929, and F1608.
Scanning electron microscopy (SEM) with energy dispersive X-ray spectroscopy (EDS) was performed on the implant endosseous threaded surface to confirm there was no residual material from the blasting or cleaning operations present on the final devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K101732, K063341, K142260, K073142, K111889
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
March 29, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym with the full name of the agency on the right. The FDA part is in blue, with the acronym in a blue square and the full name "U.S. Food & Drug Administration" written in blue text next to it.
ids - integrated dental systems % Kevin Thomas Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K180924
Trade/Device Name: Reflect™ Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: February 27, 2019 Received: February 28, 2019
Dear Kevin Thomas:
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.
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Mary S. Mary S. Runner -S3 Runner -S3 Date: 2019.03.29
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Reflect™ Implant System
Indications for Use (Describe)
Reflect™ Dental Implants are indicated for use in partially or fully edentulous patients to support maxillary and mandbular single-unit, multiple-unit, and overdenture dental restorations. Reflect™ Dental Implants are indicated loading when good primary stability is achieved and with appropriate occlusal loading.
Reflect™ Implant System prosthetic components are compatible with the following implant systems.
| Implant System
Compatibility | Implant Body Diameter
(mm) | Platform Diameter
(mm) |
|---------------------------------|-------------------------------|---------------------------|
| OsseoSpeed™ | 3.5 | 3.5/4.0 |
| | 4.0 | 3.5/4.0 |
| | 5.0 | 4.5/5.0 |
| 3i Certain® | 3.25 | 3.4 |
| | 4.0 | 4.1 |
| | 5.0 | 5.0 |
| NobelActive® | 3.5 | NP |
| | 4.3 | RP |
| | 5.0 | RP |
| NobelReplace Conical | 3.5 | NP |
| | 4.3 | RP |
| | 5.0 | RP |
| Tapered Screw-Vent® | 3.7 | 3.5 |
| | 4.1 | 3.5 |
| | 4.7 | 4.5 |
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
ids – integrated dental solutions
Reflect™ Implant System
March 28, 2019
ADMINISTRATIVE INFORMATION
| Manufacturer Name | ids – integrated dental systems | ||
|---|---|---|---|
| 300 Sylvan Avenue, Suite 104 | |||
| Englewood Cliffs, NJ 07632 | |||
| Telephone: | +1 201-676-2456 | ||
| Fax: | +1 888-788-3297 | ||
| Official Contact | Matthew Grella, Quality Assurance & Regulatory Affairs Director | ||
| Representative/Consultant | Kevin A. Thomas, PhD | ||
| Floyd G. Larson, MS, MBA | |||
| PaxMed International, LLC | |||
| 12264 El Camino Real, Suite 400 | |||
| San Diego, CA 92130 | |||
| Telephone: | +1 858-792-1235 | ||
| Fax: | +1 858-792-1236 |
kthomas(@paxmed.com flarson@paxmed.com
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | Reflect™ Implant System |
|---|---|
| Common Name | Endosseous dental implant |
| Endosseous dental implant abutment | |
| Classification Regulations | 21 CFR 872.3640 |
| Primary Product Code | DZE |
| Secondary Product Code | NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
Email:
PREDICATE DEVICE INFORMATION
Primary predicate device: K120414, OsseoSpeed™ Plus, Astra Tech AB
Reference devices: Compatible Systems K101732, Astra Tech Implant System, Astra Tech AB K063341, 3i OSSEOTITE® Certain® Dental Implants, Implant Innovations, Inc. K142260, NobelActive®, Nobel Biocare AB K073142, NobelReplace Hexagonal Implant, Nobel Biocare AB K111889, Tapered Screw-Vent® M, Zimmer Dental, Inc.
4
INDICATIONS FOR USE STATEMENT
Reflect™ Dental Implants are indicated for use in partially or fully edentulous patients to support maxillary and mandibular single-unit, multiple-unit, and overdenture dental restorations. Reflect™ Dental Implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Reflect™ Implant System prosthetic components are compatible with the following implant systems.
| Implant System Compatibility | Implant Body Diameter (mm) | Platform Diameter (mm) |
|---|---|---|
| OsseoSpeedTM | 3.5 | 3.5/4.0 |
| 4.0 | 3.5/4.0 | |
| 5.0 | 4.5/5.0 | |
| 3i Certain® | 3.25 | 3.4 |
| 4.0 | 4.1 | |
| 5.0 | 5.0 | |
| NobelActive® | 3.5 | NP |
| 4.3 | RP | |
| 5.0 | RP | |
| NobelReplace Conical | 3.5 | NP |
| 4.3 | RP | |
| 5.0 | RP | |
| Tapered Screw-Vent® | 3.7 | 3.5 |
| 4.1 | 3.5 | |
| 4.7 | 4.5 |
DEVICE DESCRIPTION
Reflect™ Implant System implants are root form endosseous dental implants with a tapered body and a grit blasted and acid etched surface intended for bone level placement. The subject device consists of five product lines (Reflect™ Aspire, Reflect™ Certus, Reflect™ Rapid, Reflect™ Recover, and Reflect™ Tapered) and three component designs (Cover Screw, Healing Abutment, and 30° Abutment). The Reflect™ implant sizes are summarized in the following table.
| Reflect TM Implant System | |||
|---|---|---|---|
| Implant Line | Body Ø (mm) | Platform Ø (mm) | Implant Lengths (mm) |
| Aspire | 3.5 | 3.5 | 8, 9, 11, 13, 15 |
| 4.0 | 4.0 | 8, 9, 11, 13, 15 | |
| 5.0 | 5.0 | 9, 11, 13, 15 | |
| Certus | 3.3 | 3.4 | 8.5, 10, 11.5, 13, 15 |
| 4.0 | 4.1 | 8.5, 10, 11.5, 13, 15 | |
| 4.9 | 5.0 | 8.5, 10, 11.5, 13, 15 | |
| Rapid | 3.5 | NP | 8.5, 10, 11.5, 13, 15 |
| 4.3 | RP | 8.5, 10, 11.5, 13, 15 | |
| 5.0 | RP | 8.5, 10, 11.5, 13, 15 | |
| Recover | 3.5 | NP | 8.5, 10, 11.5, 13, 16 |
| 4.3 | RP | 8.5, 10, 11.5, 13, 16 | |
| 5.0 | RP | 8.5, 10, 11.5, 13, 16 | |
| Tapered | 3.7 | 3.5 | 8.5, 10, 11.5, 13, 16 |
| 4.1 | 3.5 | 8.5, 10, 11.5, 13, 16 | |
| 4.7 | 4.5 | 8.5, 10, 11.5, 13, 16 |
5
| Reflect™ Implant System - Abutments | Compatible Implants | |||
|---|---|---|---|---|
| Implant Line | Abutments | Abutment | ||
| Platform Ø (mm) | Implant System | |||
| Compatibility | Platform | |||
| Diameters (mm) | ||||
| Aspire | Aspire Cover Screw | 3.5, 4.0, 5.0 | OsseoSpeed™ | 3.5/4.0, 4.5/5.0 |
| Aspire Ø 3.5/4.0 mm Healing Abutment | 3.5, 4.0 | OsseoSpeed™ | 3.5/4.0 | |
| Aspire Ø 4.5/5.0 mm Healing Abutment | 5.0 | OsseoSpeed™ | 4.5/5.0 | |
| Aspire 30° Abutment | 3.5, 4.0, 5.0 | OsseoSpeed™ | 3.5/4.0, 4.5/5.0 | |
| Certus | Certus Cover Screw 3.4/4.1 mm | 3.4, 4.1 | 3i Certain® | 3.4, 4.1 |
| Certus Cover Screw 5.0 mm | 5.0 | 3i Certain® | 5.0 | |
| Certus Healing Abutment | 3.4, 4.1, 5.0 | 3i Certain® | 3.4, 4.1, 5.0 | |
| Certus 30° Abutment | 3.4, 4.1, 5.0 | 3i Certain® | 3.4, 4.1, 5.0 | |
| Rapid | Rapid Cover Screw | NP, RP | NobelActive® | NP, RP |
| Recover/Rapid Healing Abutment | NP, RP | NobelActive® | NP, RP | |
| Rapid 30° Abutment | NP, RP | NobelActive® | NP, RP | |
| Recover | Recover Cover Screw | NP, RP | NobelReplace Conical | NP, RP |
| Recover/Rapid Healing Abutment | NP, RP | NobelReplace Conical | NP, RP | |
| Recover 30° Abutment | NP, RP | NobelReplace Conical | NP, RP | |
| Tapered | Tapered Cover Screw | 3.5, 4.5 | Tapered Screw-Vent® | 3.5, 4.5 |
| Tapered Healing Abutment | 3.5, 4.5 | Tapered Screw-Vent® | 3.5, 4.5 | |
| Tapered 30° Abutment | 3.5, 4.5 | Tapered Screw-Vent® | 3.5, 4.5 |
The Reflect™ abutment sizes are summarized in the following table. Note: each abutment is provided in each platform diameter listed.
Subject device implants are made of unalloyed titanium conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50400, UNS R50550, UNS R50700) Grade 4, and subject device abutments are made of titanium alloy conforming to ASTM F 136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
The subject device implant surface is produced by blasting with alumina (Al2O3) powder, and etching with hydrochloric acid and sulfuric acid. After etching, the remaining acid is removed by washing with distilled water, followed by cleaning with an alkaline solution using a high temperature and high-pressure hydrothermal method.
PERFORMANCE DATA
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: sterilization validation according to ISO 11137-1, ISO 11137-2, ISO 17665-1, and 17665-2; biocompatibility according to ISO 10993-1, 10993-5, and 10993-12; dynamic compression-bending testing according to ISO 14801; and engineering and dimensional analysis of the OEM implant bodies, OEM abutments, and OEM fixation screws. No clinical data were included in this submission.
6
For components provided sterile (implants, cover screws, and healing abutments) bacterial endotoxin testing was performed according to ANSI/AAMI ST72. Sterile barrier shelf testing was performed according to ASTM standards F88. F1140. F2096, F1929, and F1608.
Scanning electron microscopy (SEM) with energy dispersive X-ray spectroscopy (EDS) was performed on the implant endosseous threaded surface to confirm there was no residual material from the blasting or cleaning operations present on the final devices.
EQUIVALENCE TO MARKETED DEVICE
Provided at the end of this summary is a table comparing the Indications for Use Statements and the technological characteristics of the subject device and the primary predicate device K120414.
The subject device is substantially equivalent to the primary predicate, K120414, in material, implant design and surface, abutment design, clinical operating principle and intended use. The subject device implants and abutments are provided in the same range of sizes and dimensions as the primary predicate as shown in the table above.
Slight differences in the language between the subject device and predicate device Indications for Use Statements do not affect the intended use as a support for single or multi-unit restorations in the maxilla or mandible for the restoration of chewing function, with immediate loading indicated when primary stability and appropriate occlusal loading are achieved. The difference is that the primary predicate has additional phrases based on specific claims or specific restrictions placed on individual devices. Also, additional language for the primary predicate is related to device types/dimensions/designs that are not included in the subject device system.
Implant connection and body design are substantially equivalent to the compatible system reference devices K101732, K063341, K142260, K073142, K111889. Engineering and dimensional analysis were conducted to confirm compatibility.
The subject device components are made of similar materials, have similar packaging and are sterilized using similar materials and processes as the primary predicate device.
CONCLUSION
The subject device and the predicate devices have the same intended use, have similar technological characteristics, and are made of similar materials. The subject device and predicate devices encompass the same range of physical dimensions, including diameter and length of the implants, and the diameter and angulation of the abutments. The subject and predicate devices are packaged in similar materials and sterilized using similar methods.
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
7
510(k) Summary Page 5 of 5
Comparison of Indications for Use Statements and Technological Characteristics
| Subject Device | Primary Predicate Device | |||
|---|---|---|---|---|
| K180924 | K120414 | |||
| Comparison | Reflect™ Implant System | OsseoSpeed™ Plus | ||
| ids - integrated dental systems | Astra Tech AB | |||
| Indications for Use Statement | Reflect™ Dental Implants are indicated for use in partially or fully edentulous | |||
| patients to support maxillary and mandibular single-unit, multiple-unit, and | ||||
| overdenture dental restorations. Reflect™ Dental Implants are indicated for | ||||
| immediate loading when good primary stability is achieved and with appropriate | ||||
| occlusal loading. | ||||
| Reflect™ Implant System prosthetic components are compatible with the | ||||
| following implant systems. | Implants: | |||
| OsseoSpeed™ Plus | ||||
| The Astra Tech Dental Implants are intended for both one- and two-stage surgical | ||||
| procedures in the following situations and with the following clinical protocols: | ||||
| • replacing single and multiple missing teeth in the mandible and maxilla, | ||||
| • immediate placement in extraction sites and in situations with a partially or | ||||
| completely healed alveolar ridge, | ||||
| • especially indicated for use in soft bone applications where implants with other | ||||
| Implant System | ||||
| Compatibility | Implant Body | |||
| Diameter (mm) | Platform Diameter | |||
| (mm) | implant surface treatments may be less effective, | |||
| OsseoSpeed™ | 3.5 | 3.5/4.0 | • immediate loading in all indications, except in single tooth situations on implants | |
| 4.0 | 3.5/4.0 | shorter than 8 mm or in soft bone (type IV) where implant stability may be | ||
| difficult to obtain and immediate loading may not be appropriate. | ||||
| 5.0 | 4.5/5.0 | The intended use for OsseoSpeed™ Plus 3.0S is limited to replacement of | ||
| 3i Certain® | 3.25 | 3.4 | maxillary lateral incisors and mandibular incisors. | |
| 4.0 | 4.1 | Abutments: | ||
| 5.0 | 5.0 | Astra Tech Implant System Plus abutments are intended to be used in conjunction | ||
| NobelActive® | 3.5 | NP | with Astra Tech Implant System Plus in fully edentulous or partially edentulous | |
| maxillary and/or mandibular arches to provide support for crowns, bridges or | ||||
| 4.3 | RP | overdentures. | ||
| 5.0 | RP | Atlantis™ Abutments: | ||
| NobelReplace Conical | 3.5 | NP | The Atlantis Abutment is intended for use with an endosseous implant to support a | |
| 4.3 | RP | prosthetic device in a partially. or completely edentulous patient. It is intended for | ||
| 5.0 | RP | use to support single and multiple tooth prostheses, in the mandible or maxilla. | ||
| The prosthesis can be cemented, screw retained or friction fit to the abutment. The | ||||
| Tapered Screw-Vent® | 3.7 | 3.5 | abutment screw is intended to secure the abutment to the endosseous implant. | |
| 4.1 | 3.5 | The Atlantis™ Crown Abutment in Zirconia is intended for use with an | ||
| 4.7 | 4.5 | endosseous implant to function as a substructure that also serves as the final | ||
| restoration, in partially or completely edentulous patients. The prosthesis is screw | ||||
| retained. The abutment screw is intended to secure the crown abutment to the | ||||
| endosseous implant. | ||||
| Design | ||||
| Implant Body Diameter (mm) | 3.3, 3.5, 3.7, 4.0, 4.1, 4.3, 4.7, 4.9, 5.0 | 3.0, 3.6, 4.2, 4.8, 5.4 | ||
| Implant Length (mm) | 8.0, 8.5, 9.0, 10, 11, 11.5, 13, 15, 16 | 6.0, 8.0, 9.0, 11, 13, 15, 17 | ||
| Implant Platform Diameter (mm) | 3.4, 3.5, 4.0, 4.1, 4.5, 5.0, NP, RP | 3.0, 3.6, 4.2, 4.8, 5.4 | ||
| Abutment Platform Diameter (mm) | 3.4, 3.5, 4.0, 4.1, 4.5, 5.0, NP, RP | 3.0, 3.6, 4.2, 4.8, 5.4 | ||
| Abutment Angle | Up to 30° | Up to 30° | ||
| Abutment/ Implant Interface | Internal Hex | Internal Hex | ||
| Materials | ||||
| Implant | Unalloyed Titanium Gr 4 | Unalloyed Titanium Gr 4 | ||
| Implant Endosseous Surface | Grit-blasted and acid-etched | OsseoSpeed | ||
| Abutment | Titanium Alloy | Titanium Alloy | ||
| Screw | Titanium Alloy | Titanium Alloy |