(374 days)
No
The summary describes a physical dental implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as restoring the patient's chewing function by supporting prosthetic devices, which is a therapeutic purpose.
No
The device is a system of dental implants and abutments used for surgical and restorative applications to support prosthetic devices and restore chewing function. Its purpose is therapeutic/restorative, not diagnostic.
No
The device description clearly outlines physical components (implants and abutments) made of materials, with specific dimensions and requiring physical testing (fatigue, cytotoxicity, sterilization, packaging). There is no mention of software as a component or function of the device.
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 device is for surgical and restorative applications within the bone of the jaw to support prosthetic devices and restore chewing function. This is a direct therapeutic and structural application within the body.
- Device Description: The description details physical components like implants and abutments, which are surgically implanted devices.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for a structural and functional purpose.
N/A
Intended Use / Indications for Use
A.B. DENTAL DEVICES® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. A.B. DENTAL DEVICES® Dental lmplants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Two Stage Implants: 122, 15, 155, 110.
P4 and P14 angled abutments are to be used only with standard platform implants 3.5 mm in diameter or larger.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
A.B. DENTAL DEVICES® Dental Implants System consists of one and two stage endosseous form dental implants, internal hexagonal and one piece implants systems. Narrow platform implants are to be used with straight abutments only. The following components are being added:
| Implant | Platform | Diameter, mm | Length, mm |
|---|---|---|---|
| I22 | Standard | 3.75 | 8, 10, 11.5, 13, 16 |
| 4.2 | 8, 10, 11.5, 13, 16 | ||
| 4.5 | 8, 10, 11.5, 13, 16 | ||
| 5 | 8, 10, 11.5, 13, 16 | ||
| I5 | Narrow | 3.3 | 10, 11.5, 13, 16 |
| I55 | Narrow | 3.3 | 10, 11.5, 13, 16 |
| 3.5 | 8, 10, 11.5, 13, 16 | ||
| Standard | 3.75 | 8, 10, 11.5, 13, 16 | |
| 4.2 | 8, 10, 11.5, 13, 16 | ||
| 4.5 | 8, 10, 11.5, 13, 16 | ||
| 5 | 8, 10, 11.5, 13, 16 | ||
| 6 | 8, 10, 11.5, 13, 16 | ||
| I10 | Standard | 4.5 | 10, 11.5, 13, 16 |
Abutments:
- P0-14 Healing caps, 2.5 7 mm heights .
- P3-5 straight abutments, 5 mm diameter, 7 9 mm length ●
- P4 angled abutments, 15 - 25 degree angulation, standard platform, standard and long lengths
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the upper or lower jaw
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)
Fatigue testing per ISO 14801:2007 of the worst-case implant and abutment combination for the standard platform implants and abutments
Engineering analysis to determine if additional components constitute a new worst-case.
Cytotoxicity testing per ISO 10993-5 and biological risk assessment
Gamma sterilization validation per ISO 11137
Steam sterilization validation per ANSI/AAMI/ISO 17665-1:2006
Packaging validation and accelerated shelf-life testing
LAL testing in accordance with the FDA Guidance on Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design. The eagle's head and neck are formed by the profiles, creating a visual representation of the department's focus on health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15, 2017
A. B. Dental Device Ltd. % John Smith, M.D., J.D. Partner Hogan Lovells US LLP 555 13th St. NW Washington, District of Columbia 20004
Re: K162482
Trade/Device Name: A.B. DENTAL DEVICES® Dental Implants System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: August 15, 2017 Received: August 15, 2017
Dear Dr. John Smith:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Andrew I. Steen -S
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
510(k) Number (if known)
Device Name
A.B. DENTAL DEVICES® Dental Implants System
Indications for Use (Describe)
A.B. DENTAL DEVICES® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. A.B. DENTAL DEVICES® Dental lmplants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Two Stage Implants: 122, 15, 155, 110.
P4 and P14 angled abutments are to be used only with standard platform implants 3.5 mm in diameter or larger.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Page 1 of 1 FDA
PSC Publishing Services (301) 443-6740 EF
3
K162482 510(k) SUMMARY A.B. Dental Devices Dental Implant System
Submitter:
A.B. Dental Devices Ltd. 19 Havalomim St., Ashdod 7761117 lsrael
Phone: 972-8-8531388 Facsimile: 972-8-8522562 Contact Person: Gabi Krauss, RA Manager
Date Prepared: September 15, 2017
Name of Device: A.B. DENTAL DEVICES® Dental Implants System Common or Usual Name: Root-form Endosseous Dental Implants & Abutments Classification Name: Endosseous dental implant; 21 CFR §872.3640 Product Code: DZE, Additional Product Code NHA
Predicate Device
K132125 A.B. DENTAL DEVICES® Dental Implants System (primary) K051719 A.B. DENTAL DEVICES® Dental Implants System (reference) K112440 A.B. DENTAL DEVICES® Dental Implants System (reference) K071370 Nobel Biocare AB NobelActive (reference)
Indications for Use
A.B. DENTAL DEVICES® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. A.B. DENTAL DEVICES® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Two Stage Implants: 122, 15, 155, 110.
P4 and P14 angled abutments are to be used only with standard platform implants 3.5 mm in diameter or larger.
4
Device Description and Technological Characteristics
A.B. DENTAL DEVICES® Dental Implants System consists of one and two stage endosseous form dental implants, internal hexagonal and one piece implants systems. Narrow platform implants are to be used with straight abutments only. The following components are being added:
| Implant | Platform | Diameter, mm | Length, mm |
|---|---|---|---|
| I22 | Standard | 3.75 | 8, 10, 11.5, 13, 16 |
| 4.2 | 8, 10, 11.5, 13, 16 | ||
| 4.5 | 8, 10, 11.5, 13, 16 | ||
| 5 | 8, 10, 11.5, 13, 16 | ||
| I5 | Narrow | 3.3 | 10, 11.5, 13, 16 |
| I55 | Narrow | 3.3 | 10, 11.5, 13, 16 |
| 3.5 | 8, 10, 11.5, 13, 16 | ||
| Standard | 3.75 | 8, 10, 11.5, 13, 16 | |
| 4.2 | 8, 10, 11.5, 13, 16 | ||
| 4.5 | 8, 10, 11.5, 13, 16 | ||
| 5 | 8, 10, 11.5, 13, 16 | ||
| 6 | 8, 10, 11.5, 13, 16 | ||
| I10 | Standard | 4.5 | 10, 11.5, 13, 16 |
Abutments:
- P0-14 Healing caps, 2.5 7 mm heights .
- P3-5 straight abutments, 5 mm diameter, 7 9 mm length ●
- P4 angled abutments, 15 - 25 degree angulation, standard platform, standard and long lengths
Technological Characteristics Comparison
The purpose of this 510(k) is to expand the current product line to include two new endosseous implant product lines (122 and 155). Minor additions to existing implant lines have also been added. Comparison tables for each modification are provided below.
| Subject I5 | Predicate I5 | Predicate I6bi | |
|---|---|---|---|
| K-number | K162482 | K132125, K112440 | K132125 |
| Material | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V |
| Diameter, mm | 3.3 | 3.5, 3.75, 4.2, 4.5, 5, 6 | 3 |
| Platform | Narrow | Standard | Narrow |
| Length, mm | 10, 11.5, 13, 16 | 8, 10, 11.5, 13, 16 | 10, 11.5, 13, 16 |
| Profile | Tapered | Tapered | Tapered |
| Surface Treatment | Sand blasted with CaP | Sand blasted with CaP | Sand blasted with CaP |
| Sterility | Sterile | Sterile | Sterile |
| Subject I10 | Predicate I10 | |
|---|---|---|
| K-number | K162482 | K112440 |
| Material | Ti-6Al-4V | Ti-6Al-4V |
| Diameter, mm | 4.5 | 3.75, 4.2, 5 |
| Platform | Standard | Standard |
| Length, mm | 10, 11.5, 13, 16 | 10, 11.5, 13, 16 |
| Profile | Tapered | Tapered |
5
| Surface Treatment | Sand blasted with CaP | Sand blasted with CaP |
|---|---|---|
| Sterility | Sterile | Sterile |
| Subject 122 | Predicate 12 | |
|---|---|---|
| K-number | K162482 | K132125, K112440 |
| Material | Ti-6Al-4V | Ti-6Al-4V |
| Diameter, mm | 3.75, 4.2, 4.5, 5 | 3.5, 3.75, 4.2, 4.5, 5, 6 |
| Platform | Standard | Standard |
| Length, mm | 8, 10, 11.5, 13, 16 | 8, 10, 11.5, 13, 16, 18, 20 |
| Profile | Tapered | Tapered |
| Surface Treatment | Sand blasted with CaP | Sand blasted with CaP |
| Sterility | Sterile | Sterile |
| Subject I55 | Predicate I5 | Predicate I6bi | |
|---|---|---|---|
| K-number | K162482 | K132125, K112440 | K132125 |
| Material | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V |
| Diameter, mm | 3.3,3.5, 3.75, 4.2, 4.5, 5, 6 | 3.5, 3.75, 4.2, 4.5, 5, 6 | 3 |
| Platform | Narrow (≤3.5) and Standard (≥3.75) | Standard | Narrow |
| Length, mm | 8, 10, 11.5, 13, 16 | 8, 10, 11.5, 13, 16 | 10, 11.5, 13, 16 |
| Profile | Tapered | Tapered | Tapered |
| Surface Treatment | Sand blasted with CaP | Sand blasted with CaP | Sand blasted with CaP |
| Sterility | Sterile | Sterile | Sterile |
| Subject P0 Healing Caps | Predicate P0 Caps | |
|---|---|---|
| K-number | K162482 | K132125 |
| Material | Ti-6Al-4V | Ti-6Al-4V |
| Connection Method | Taper fit | Screw |
| Platform | P14 angled abutments | Narrow, Standard |
| Length, mm | 2.5, 4, 5, 7 | 0.5, 2, 3, 4, 5, 6, 7 |
| Sterility | Non-Sterile | Non-Sterile |
| Subject P3-5 | Predicate P3 | |
|---|---|---|
| K-number | K162482 | K132125, K112440 |
| Material | Ti-6Al-4V | Ti-6Al-4V |
| Diameter, mm | 5 | 3.75, 4.5, 5.5 |
| Platform | Standard | Narrow, Standard |
| Length, mm | 7,9 | 5, 7, 9, 11,12, 15 |
| Design | Anti-rotation | Anti-rotation |
| Sterility | Non-Sterile | Non-Sterile |
| Subject P4 | Predicate P4 | |
|---|---|---|
| K-number | K162482 | K132125 |
| Material | Ti-6Al-4V | Ti-6Al-4V |
| Diameter, mm | 3.75, 5 | 3.75 |
| Angle, ° | 15, 25 | 15 |
| Platform | Standard | Standard |
6
| Length, mm | 8, 9, 15.5 | 15.7 |
|---|---|---|
| Design | Straight, Standard, Narrow, Long | Long, Anatomic (shoulder heights 1,3) |
| Sterility | Non-Sterile | Non-Sterile |
In addition, a comparison of the indications for use of the subject and primary predicate follows:
| | Subject A.B. DENTAL DEVICES®
Dental Implants System | Primary Predicate A.B. DENTAL DEVICES®
Dental Implants System |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K-number | K162482 | K132125 |
| Indications for Use | A.B. DENTAL DEVICES® Dental
Implants System is indicated for
use in surgical and restorative
applications for placement in the
bone of the upper or lower jaw to
provide support for prosthetic
devices, such as artificial teeth, in
order to restore the patient's
chewing function. A.B. DENTAL
DEVICES® Dental Implants System
is indicated also for immediate
loading when good primary
stability is achieved and with
appropriate occlusal loading.
Two Stage Implants: I22, I5, I55,
I10.
P4 and P14 angled abutments are to
be used only with standard platform
implants 3.5 mm in diameter or
larger. | A.B.DENTAL DEVICES® Dental Implants
System is indicated for use in surgical and
restorative applications for placement in
the bone of the upper or lower jaw to
provide support for prosthetic devices,
such as artificial teeth, in order to restore
the patient's chewing function. A.B.
DENTAL DEVICES® Dental Implants
System is indicated also for immediate
loading when good primary stability is
achieved and with appropriate occlusal
loading.
Two Stage Implants: I2, I5, I6BI.
One Stage: I6, I6b, I6B.
One Stage & One-Piece 3.0 mm diameter
implants: I6, I6B, I6BI, are intended for
placement at the mandibular central and
lateral incisors and maxillary and lateral
incisors. Indicated also for denture
stabilization using multiple implants.
One stage & One-Piece 2.4 mm diameter
implants for temporary use or long term
use: I6, I6b, permit immediate splint
stability and long term fixation of new or
existing crown, bridge and prosthesis.
P14 Angulated Abutment Adapter is to be
used with implant diameter 4.2mm and
higher. |
With regard to differences in the indications for use between the subject and primary predicate:
- . The list of two stage implants was updated to include the new endosseous implant product lines.
- Limitations for the 2.4 mm and 3.0 diameter implant bodies are not included because the subject ● devices do not contain any of that size.
- One stage indications were removed because the subject devices are only indicated for two stage. ●
- The indication for the P14 abutment was reduced to the standard platform implant diameter of 3.5 mm . or larger based on the fatigue testing provided.
Performance Data
Fatigue testing per ISO 14801:2007 of the worst-case implant and abutment combination for the standard platform implants and abutments Engineering analysis to determine if additional components constitute a new worst-case.
7
Cytotoxicity testing per ISO 10993-5 and biological risk assessment Gamma sterilization validation per ISO 11137 Steam sterilization validation per ANSI/AAMI/ISO 17665-1:2006 Packaging validation and accelerated shelf-life testing LAL testing in accordance with the FDA Guidance on Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile
Substantial Equivalence
The AB Dental Implant System has the same indications and similar technological characteristics and principles of operation as its predicate device. The minor technological differences between the AB Dental Implant Systems do not raise different issues. Performance data demonstrate that the AB Dental Implant System is substantially equivalent.
Conclusions
The AB Dental Implant System is substantially equivalent to the predicate device.