(226 days)
No
The summary describes a physical dental implant and its materials, design, and testing, with no mention of software, algorithms, or AI/ML capabilities.
No
Explanation: A therapeutic device is designed to treat or alleviate a medical condition. This device, a dental implant, is intended to replace missing teeth and support restorations, which is a restorative and prosthetic function, not a direct therapeutic treatment of a disease or condition. While it improves quality of life and functionality, its primary role is structural replacement rather than active therapy.
No
This device, Simply Iconic™ dental implants, is a dental implant system used for supporting dental restorations in partially and fully edentulous jaws. Its purpose is to replace missing teeth, not to diagnose medical conditions or diseases.
No
The device description clearly details physical components made of titanium, including the implant body, threads, flutes, cover screw, and healing collar. This indicates a hardware medical device, not a software-only one.
Based on the provided text, the Simply Iconic™ dental implant is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Simply Iconic™ Function: The description clearly states that the Simply Iconic™ dental implant is a device intended for surgical implantation into the jawbone to support dental restorations. It is a physical implant, not a tool for analyzing biological samples.
- Intended Use: The intended use is for supporting dental prosthetics in the mouth, not for diagnostic testing.
Therefore, the Simply Iconic™ dental implant falls under the category of a medical device, specifically a dental implant, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Simply Iconic™ dental implants are two-piece implants for one-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
• Narrow (3.2mmD) implants: Indicated for single-tooth replacement (mandibular central and lateral incisors; maxillary lateral incisors), multiple-tooth replacements or denture stabilization.
• Short (6mm) 3.7mmD implants: Indicated for single-tooth (mandibular and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The Simply Iconic™ implants are two-piece dental implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
The top one-third (coronal part) of the Simply Iconic™ implant body is straight, with quadruple-lead micro-threads on the coronal aspect, and the lower two-thirds is tapered with dual-lead progressively deeper buttress threads. This design is intended for increased bone-to-implant contact (BIC). Three cutting flutes extend over the tapered portion of the implant body to make bone tapping unnecessary for implant insertion.
The dental implant body are available in several diameter sizes (ranging from 3.2mmD - 7.0mmD), platform diameters (3.0, 3.4mmD) and lengths (ranging from 6 - 16 mm). These options are listed in Table 1 below. These variations provide flexibility for clinicians to address patients' various bone structures/mouth anatomies.
The Simply Iconic™ dental implants utilize the same implant abutment interface as the Implant Direct InterActive implants and are compatible with corresponding 3.0 and 3.4 mm platform InterActive abutments.
The Simply Iconic™ dental implants are composed of titanium 6AI4V ELI metal, anodized titanium 6Al4V ELI colors (magenta or gold). Soluble Blast Media (SBM) surface treatments with Hydroxyapatite (HA) blast media. SBM implant surfaces have a micro texture created on defined areas of the implant. The Simply Iconic™ dental implants are packaged sterile supplied with a cover screw and a 5mm healing collar.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower jaws
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)
The design differences between the subject and predicate device was evaluated through biocompatibility, sterilization, shelf life, simulated distribution, fatique, surface area and bone-to-implant analysis, simulated pull out testing, and insertion torque testing. The documentation submitted in the premarket notification demonstrates that the Simply Iconic™ Implants are substantially equivalent to the predicate device.
Biocompatibility: The Simply Iconic™ Implants were evaluated for biocompatibility in accordance with ISO 10993-1 and the subject devices were successfully tested for Cytotoxicity per ISO 10993-5, Irritation and Sensitization per ISO 10993-10, Systemic Toxicity and Chronic Toxicity per ISO 10993-11 (with the exception of material-mediated pyrogen testing as the subject devices not being represented to be non-pyrogenic devices), Implantation per ISO 10993-6, as well as Genotoxicity and Carcinogenicity per ISO 10993-3. The results demonstrated that the subject devices are considered biocompatible and pose no anticipated risk to the patient for the intended clinical application.
Distribution: The Simply Iconic™ Implants were subjected to distribution testing to determine any impact distribution would have on the subject device. Worst-case implants were subjected to simulated shipping following ASTM D4169, DC 13, Assurance Level II. Tests included handling, stacking, loose load vibration, vehicle vibration, concentrated impact. All implant subjected to the distribution testing passed the QA inspection prior to and after the distribution simulation.
Fatique testing: The Simply Iconic™ Implants were subjected to fatique performance testing according to ISO 14801 Dynamic Loading Test for Endosseous Dental Implants, and Section 8 of "Guidance for Industry and FDA Staff" - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. Results were favorably compared to both primary and reference predicates.
Surface area and bone-to-implant contact analysis: The Simply Iconic™ Implants were subjected to surface area and bone-to-implant contact analysis. Both surface area and bone-to-impact comparisons were made to the primary predicate (K130572) and reference predicate (K131097) 6mm length implant designs. Results of the analysis showed that the subject device has greater surface area and bone-to-implant contact than the predicate.
Simulated pullout testing: The Simply Iconic™ Implants were subjected to simulated pullout testing. Osteotomies were made in simulated bone and subject device, primary predicate (K130572) 6mm length implants, and reference predicate (K131097) 6mm length implants were inserted to a depth of 3mm below the implant bone level. The force required to remove the implants was recorded. Results of the testing showed that the subject device has greater pullout force than the predicates.
Insertion torque testing: The Simply Iconic™ Implants were subjected to insertion torque testing. Osteotomies were made in simulated bone and subject device, primary predicate (K130572) 6mm length implants, and reference predicate (K131097) 6mm length implants were inserted. The torque required to place the implants was recorded. Results of the testing showed that the subject device has comparable insertion torque as the predicates.
Sterilization testing: The Simply Iconic™ Implants were subjected to sterilization testing. Sterilization validation testing was performed per ISO 11137-2 to verify the ability of Implant Direct's established VDmax radiation sterilization process. The validation successfully demonstrated a sterility assurance level (SAL) of 10° for the subject devices.
Shelf life Validation: The real-time shelf life validation was conducted on the equivalent devices with same sterile barrier packaging system per ISO 11607-1 and the results verified that the Simply Iconic™ Implants can maintain sterility for 5 years per ISO 11737-1 and ISO 11737-2.
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.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Implant Direct Sybron Manufacturing, LLC Reina Choi Regulatory Affairs Manager 3050 East Hillcrest Drive Thousand Oaks, California 91362
Re: K201553
Trade/Device Name: Simply IconicTM Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: December 22, 2020 Received: December 22, 2020
Dear Reina Choi:
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 (OS) 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 Steen Assistant Director DHT1B: Division of Dental 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
Indications for Use
510(k) Number (if known) K201553
Device Name Simply Iconic™ Implants
Indications for Use (Describe)
Simply Iconic™ dental implants are two-piece implants for one-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
• Narrow (3.2mmD) implants: Indicated for single-tooth replacement (mandibular central and lateral incisors; maxillary lateral incisors), multiple-tooth replacements or denture stabilization.
· Short (6mm) 3.7mmD implants: Indicated for single-tooth (mandibular and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization.
Type of Use (Select one or both, as applicable)2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
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4
510(k) Summary
I. SUBMITTER
Implant Direct Sybron Manufacturing, LLC 3050 East Hillcrest Drive Thousand Oaks, CA 91362
Contact Person: Reina Choi, Regulatory Affairs Manager E-mail: reina.choi@implantdirect.com Phone: (818) 307-3132
Date Prepared: January 22, 2021
II. DEVICE
Name of Device: Simply Iconic ™ Implants Common or Usual Name: Endosseous Dental Implant Classification Name: Implant, Endosseous, Root-Form (21 CFR 872.3640) Requlatory Class: II Product Code: DZE
III.PREDICATE DEVICE
Predicate (primary) InterActive/SwishPlus2 Implant System (K130572)
Predicate (reference) Spectra-System Dental Implants 2008 (K090234) Legacy3 6mm Length Implants (K131097)
IV. DEVICE DESCRIPTION
The Simply Iconic™ implants are two-piece dental implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
The top one-third (coronal part) of the Simply Iconic™ implant body is straight, with quadruple-lead micro-threads on the coronal aspect, and the lower two-thirds is tapered with dual-lead progressively deeper buttress threads. This design is intended for increased bone-to-implant contact (BIC). Three cutting flutes extend over the tapered portion of the implant body to make bone tapping unnecessary for implant insertion.
The dental implant body are available in several diameter sizes (ranging from 3.2mmD
5
- 7.0mmD), platform diameters (3.0, 3.4mmD) and lengths (ranging from 6 - 16 mm). These options are listed in Table 1 below. These variations provide flexibility for clinicians to address patients' various bone structures/mouth anatomies.
| Body Diameter | Platform Diameter | Length |
|---|---|---|
| 3.2mmD | 3.0mmD | 8, 10, 11.5, 13, and 16 mm |
| 3.7mmD | 3.0mmD | 6, 8, 10, 11.5, 13, and 16 mm |
| 4.2mmD | 3.0mmD | 6, 8, 10, 11.5, 13, and 16 mm |
| 4.7mmD | 3.0mmD | 6, 8, 10, 11.5, 13, and 16 mm |
| 4.7mmD | 3.4mmD | 6, 8, 10, 11.5, 13, and 16 mm |
| 5.2mmD | 3.4mmD | 6, 8, 10, 11.5, and 13 mm |
| 5.7mmD | 3.4mmD | 6, 8, 10, 11.5, and 13 mm |
Table 1: Dimensions for Simply Iconic™ Implants
The Simply Iconic™ dental implants utilize the same implant abutment interface as the Implant Direct InterActive implants and are compatible with corresponding 3.0 and 3.4 mm platform InterActive abutments.
The Simply Iconic™ dental implants are composed of titanium 6AI4V ELI metal, anodized titanium 6Al4V ELI colors (magenta or gold). Soluble Blast Media (SBM) surface treatments with Hydroxyapatite (HA) blast media. SBM implant surfaces have a micro texture created on defined areas of the implant. The Simply Iconic™ dental implants are packaged sterile supplied with a cover screw and a 5mm healing collar.
V. INDICATIONS FOR USE
Simply Iconic™ dental implants are two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
- Narrow (3.2mmD) implants: Indicated for single-tooth replacement (mandibular . central and lateral incisors; maxillary lateral incisors), multiple-tooth replacements or denture stabilization.
- Short (6mm) 3.7mmD implants: Indicated for single-tooth (mandibular and . maxillary central and lateral incisors), multiple tooth replacements or denture stabilization.
6
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS (SUBJECT DEVICE AND PRIMARY PREDICATE)
| Technological
| characteristics | Subject Device | Predicate (primary) | Comparison | |
|---|---|---|---|---|
| Simply Iconic™ Implants | ||||
| (K201553) | InterActive/SwishPlus2 | |||
| Implant System | ||||
| (K130572) | ||||
| Design Characteristic | Manufacturer | Implant Direct Sybron Manufacturing, | ||
| LLC | Implant Direct Sybron Manufacturing, | |||
| LLC | Same | |||
| General design | Threaded root form implant | Threaded root form implant | Same | |
| Material | Titanium 6AL4V ELI | Titanium 6AL4V ELI | Same | |
| Coating/Surface | ||||
| Treatment | HA blasted SBM implants | - HA blasted SBM implants |
- HA blasted HA coated implants | The predicate includes SBM
implants |
| | Body diameters | 3.2, 3.7, 4.2, 4.7, 5.2, 5.7mm | 3.2, 3.7, 4.3, 5.0mm | The subject device has 5.2 and
5.7mm diameter implants outside the
scope of the predicate |
| | Body Lengths | 6, 8, 10, 11.5, 13, 16mm | 6, 8, 10, 11.5, 13, 16mm | Same |
| | Implant Platform
and connection
type | 3.0 and 3.4mm platform with internal
hex and conical connection | 3.0 and 3.4mm platform with internal
hex and conical connection | Same connector design and size |
| | Screw size | M1.6 and M2 | M1.6 and M2 | Same screw designs |
| | Intended use | Simply Iconic™ Implant consists of
two-piece implants for one-stage or
two-stage surgical procedures. These
implants are intended for use in
partially and fully edentulous upper and
lower jaws in support of single of
multiple-unit restorations and terminal
or intermediate abutment support for
fixed bridgework. | InterActive/SwishPlus2 Implant
System consists of two-piece implants
for one-stage or two-stage surgical
procedures. These implants are
intended for use in partially and fully
edentulous upper and lower jaws in
support of single of multiple-unit
restorations and terminal or
intermediate abutment support for
fixed bridgework. | Same intended use except for device
name |
| Technological
characteristics | Subject Device | Predicate (primary) | Comparison | |
| Indication for Use | Simply Iconic™ Implants
(K201553)
Simply Iconic™ dental implants are
two-piece implants for one-stage or
two-stage surgical procedures. These
implants are intended for use in
partially and fully edentulous upper and
lower jaws in support of single or
multiple-unit restorations and terminal
or intermediate abutment support for
fixed bridgework.
Implants can be indicated for
immediate loading when good primary
stability has been achieved and with
appropriate occlusal loading.
• Narrow (3.2mmD) implants:
Indicated for single-tooth
replacement (mandibular central
and lateral incisors; maxillary lateral
incisors), multiple-tooth
replacements or denture
stabilization.
• Short (6mm) 3.7mmD implants:
Indicated for single-tooth
(mandibular and maxillary central
and lateral incisors), multiple tooth
replacements or denture
stabilization.
• | InterActive/SwishPlus2
Implant System
(K130572)
InterActive/SwishPlus2 Implant
System consists of two-piece implants
for one-stage or two-stage surgical
procedures. These implants are
intended for use in partially and fully
edentulous upper and lower jaws in
support of single or multiple-unit
restorations and terminal or
intermediate abutment support for
fixed bridgework: Implants can be
indicated for immediate loading when
good primary stability has been
achieved and with appropriate
occlusal loading.
Narrow Diameter (3.2, 3.3mm)
Implants: Indicated for single-tooth
replacement of mandibular central
and lateral incisors and maxillary
lateral incisors. Also indicated for
multiple tooth replacements or
denture stabilization.
Compatibility: InterActive and
SwishPlus2 implants are
prosthetically compatible with
InterActive 3.0 and 3.4mm abutments
and Nobel Biocare conical connection
NobelActive™ NP (Narrow Platform -
3.0mm diameter) and NobelActive™
RP (Regular Platform - 3.4mm
diameter) abutments. InterActive 3.0
and 3.4mm abutments are | Both implants are two-piece for one
stage or two stage procedures.
Both implants are intended for
partially and fully edentulous upper
and lower jaws in support of single or
multiple-unit restorations and
terminal or intermediate abutment
support for fixed bridgework
Both implants are indicated for
immediate loading when good
primary stability has been achieved
and with appropriate occlusal loading
Both implants limit narrow diameter
implants to single-tooth replacement
of mandibular central and lateral
incisors and maxillary lateral incisors
and for multiple tooth replacement
and denture stabilization
The subject device limits 6mm 3.7D
implants to single-tooth mandibular
and maxillary central and lateral
incisors, multiple tooth replacements
or denture stabilization.
The subject device excludes 6mm
implants for use with titanium custom
abutments. | |
7
8
| Technological
| characteristics | Subject Device | Predicate (primary) |
|---|---|---|
| Simply Iconic™ Implants | ||
| (K201553) | InterActive/SwishPlus2 | |
| Implant System | ||
| (K130572) | ||
| prosthetically compatible with Nobel | ||
| Biocare conical connection. | ||
| NobelActive™ NP (Narrow Platform- | ||
| 3.0mm diameter) and NobelActive™ | ||
| RP (Regular Platform - 3.4mm | ||
| diameter) (3.5-5.0mmD, 8.5- | ||
| 18mmLength) implants. | The predicate specifies compatibility | |
| devices not placed on the market by | ||
| Implant Direct. The subject device | ||
| does not make such compatibility | ||
| claims. | ||
| Comparison |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS (SUBJECT DEVICE AND REFERENCE PREDICATES)
| Technological
| characteristics | Subject Device | Predicate (reference) | Predicate (reference) | ||
|---|---|---|---|---|---|
| Simply Iconic™ Implants | |||||
| (K201553) | Spectra-System Dental | ||||
| Implants 2008 | |||||
| (K090234) | Legacy3 6mm Length | ||||
| Implants | |||||
| (K131097) | Comparison | ||||
| Design Characteristic | Manufacturer | Implant Direct Sybron | |||
| Manufacturing, LLC | Implant Direct Sybron | ||||
| Manufacturing, LLC | Implant Direct Sybron | ||||
| Manufacturing, LLC | Same | ||||
| General design | Threaded root form implant | Threaded root form implant | Threaded root form implant | Same | |
| Material | Titanium 6AL4V ELI | Titanium 6AL4V ELI | Titanium 6AL4V ELI | Same | |
| Coating/Surface | |||||
| Treatment | HA blasted SBM implants | HA blasted SBM Implants | HA blasted SBM implant | Same | |
| Body diameters | 3.2, 3.7, 4.2, 4.7, 5.2, | ||||
| 5.7mm | 3.2, 3.7, 4.2, 4.7, 5.2, | ||||
| 5.7mm | 3.7, 4.2, 4.7, 5.2, 5.7, | ||||
| 7.0mm | Body diameter of subject | ||||
| device is the same as | |||||
| K090234 | |||||
| Body Lengths | 6, 8, 10, 11.5, 13, 16mm | 8, 10, 11.5, 13, 16mm | 6mm | Body length of subject | |
| device is within the range of | |||||
| the reference devices. | |||||
| Implant Platform | |||||
| and connection | |||||
| type | 3.0 and 3.4mm platform | ||||
| with internal hex and | |||||
| conical connection | 3.0, 3.5, 4.5, 5.7mm with | ||||
| internal hex and bevel | |||||
| connection | 3.5, 4.5, 5.7mm with | ||||
| internal hex and bevel | |||||
| connection | Subject device uses internal | ||||
| hex like both reference | |||||
| devices. Subject device |
9
| | Technological
characteristics | Subject Device | Predicate (reference) | Predicate (reference) | Comparison |
|--|----------------------------------|--------------------------------------|-----------------------------------------------------|---------------------------------------------|-----------------------------------------------------------------------|
| | | Simply Iconic™ Implants
(K201553) | Spectra-System Dental
Implants 2008
(K090234) | Legacy3 6mm Length
Implants
(K131097) | platform size is within range
of the reference devices |
| | Screw size | M1.6 and M2 | M1.6 and 1-72 UNF | 1-72 UNF | Screw sizes of subject and
reference predicates are
comparable. |
10
Analysis of Differences Between Subject Device and Predicates
The Simply Iconic™ dental implants are made from the same materials having same surface treatment with identical prosthetic interfaces and general design features as the primary and reference predicates.
The Simply Iconic™ dental implants differ from primary predicate (K130572) by offering additional body diameters to provide end users with a wider range of options. The Simply Iconic™ implants also offer a longer quadruple lead threads in the coronal region, similarly to the reference predicates, instead of offering micro grooves as in the primary predicate device, which allows for slightly higher insertion torque in soft-bone protocols and a higher pullout retention force for better initial worst-case engagement with bone.
Except for the device name the intended use of the primary predicate (K130572) and subject device Simply Iconic™ are the same. The subject device indications for use differs from the primary predicate (K130572) in two ways. First, the subject device limits narrow 3.2D implants and 6mm 3.7D implants to single-tooth mandibular and maxillary central and lateral incisors. multiple tooth replacements or denture stabilization. Second, the primary predicate specifies compatibility devices not placed on the market by Implant Direct. The subject device does not make such compatibility claims. Refer to the comparison table for a detailed comparison of the primary predicate (K130572) and subject device indications for use.
Summary:
The design differences between the subject and predicate device was evaluated through biocompatibility, sterilization, shelf life, simulated distribution, fatique, surface area and bone-to-implant analysis, simulated pull out testing, and insertion torque testing. The documentation submitted in the premarket notification demonstrates that the Simply Iconic™ Implants are substantially equivalent to the predicate device.
VII. PERFORMANCE DATA
Summary of Non-Clinical Testing:
Biocompatibilitv
The Simply Iconic™ Implants were evaluated for biocompatibility in accordance with ISO 10993-1 and the subject devices were successfully tested for Cytotoxicity per ISO 10993-5, Irritation and Sensitization per ISO 10993-10, Systemic Toxicity and Chronic Toxicity per ISO 10993-11 (with the exception of material-mediated pyrogen testing as the subject devices not being represented to be non-pyrogenic devices), Implantation per ISO 10993-6, as well as Genotoxicity and Carcinogenicity per ISO 10993-3. The results demonstrated that the subject devices are considered biocompatible and pose no anticipated risk to the patient for
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the intended clinical application. The endotoxins level is determined based on LAL test in accordance with ANSI/AAMI ST72 and is performed twice a year for final products and with every new product manufactured on site per United States Pharmacopeia Convention, Inc. USP and . The testing limit is 20 EU per device or 0.5 EU per ml respectively in accordance with the requirements set out in FDA Guidance "Pyrogen and Endotoxins Testing: Questions and Answers." The results of the testing were used to address questions related to substantial equivalence based on differences in product design between the subject and predicate device (K130572).
Distribution
The Simply Iconic™ Implants were subjected to distribution testing to determine any impact distribution would have on the subject device. Worst-case implants were subjected to simulated shipping following ASTM D4169, DC 13, Assurance Level II. Tests included handling, stacking, loose load vibration, vehicle vibration, concentrated impact. All implant subjected to the distribution testing passed the QA inspection prior to and after the distribution simulation. The results of the testing were used to address questions related to substantial equivalence based on differences in product packaging between the subject and predicate device (K130572)
Fatique testing
The Simply Iconic™ Implants were subjected to fatique performance testing according to ISO 14801 Dynamic Loading Test for Endosseous Dental Implants, and Section 8 of "Guidance for Industry and FDA Staff" - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. Results were favorably compared to both primary and reference predicates. The results of the testing were used to address questions related to substantial equivalence based on differences in product design between the subject and predicate device (K130572) as well as the reference predicate device (K090234).
Surface area and bone-to-implant contact analysis
The Simply Iconic™ Implants were subjected to surface area and bone-to-implant contact analysis. Both surface area and bone-to-impact comparisons were made to the primary predicate (K130572) and reference predicate (K131097) 6mm length implant designs. Results of the analysis showed that the subject device has greater surface area and bone-to-implant contact than the predicate. The results of the testing were used to address questions related to substantial equivalence based on differences in product design between the subject and primary predicate device (K130572) as well as the reference predicate device (K131097).
Simulated pullout testing
The Simply Iconic™ Implants were subjected to simulated pullout testing. Osteotomies were made in simulated bone and subject device, primary predicate (K130572) 6mm length implants, and reference predicate (K131097) 6mm length
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implants were inserted to a depth of 3mm below the implant bone level. The force required to remove the implants was recorded. Results of the testing showed that the subject device has greater pullout force than the predicates. The results of the testing were used to address questions related to substantial equivalence based on differences in product design between the subject and primary predicate device (K130572) as well as the reference predicate device (K131097).
Insertion torque testing
The Simply Iconic™ Implants were subjected to insertion torque testing. Osteotomies were made in simulated bone and subject device, primary predicate (K130572) 6mm length implants, and reference predicate (K131097) 6mm length implants were inserted. The torque required to place the implants was recorded. Results of the testing showed that the subject device has comparable insertion torque as the predicates. The results of the testing were used to address questions related to substantial equivalence based on differences in product design between the subject and primary predicate device (K130572) as well as the reference predicate device (K131097).
Sterilization testing
The Simply Iconic™ Implants were subjected to sterilization testing. Sterilization validation testing was performed per ISO 11137-2 to verify the ability of Implant Direct's established VDmax radiation sterilization process. The validation successfully demonstrated a sterility assurance level (SAL) of 10° for the subject devices. The results of the testing were used to address questions related to substantial equivalence based on differences in product design between the subject and primary predicate device (K130572).
Shelf life Validation
The real-time shelf life validation was conducted on the equivalent devices with same sterile barrier packaging system per ISO 11607-1 and the results verified that the Simply Iconic™ Implants can maintain sterility for 5 years per ISO 11737-1 and ISO 11737-2. The results of the testing were used to address questions related to substantial equivalence based on differences in product design between the subject and primary predicate device (K130572) as well as the reference predicate device (K090234).
VIII. CONCLUSIONS
The Simply Iconic™ Implants were evaluated for substantial equivalence using standard and/or comparative testing. Based on technological characteristics and non-clinical test data included in this submission, the Simply Iconic™ Implants have been shown to be substantially equivalent to the InterActive/SwishPlus2 Implant System (K130572).