(65 days)
Not Found
No
The summary describes a dental implant and its intended use, materials, and dimensions. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No
The device is described as a dental implant used to restore chewing function by serving as anchorage for dental restorations, rather than treating or preventing a disease or condition.
No
The device is a dental implant intended to restore chewing function, not to diagnose a condition.
No
The device description clearly describes a physical implant made of titanium alloy with an HA coating, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to restore chewing function by serving as anchorage for dental restorations. This is a therapeutic and structural function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a titanium alloy implant with an HA coating, designed to be surgically placed in bone. This is a medical device for implantation, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
Therefore, the Replace HA Coated Implant is a medical device intended for surgical implantation, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Replace HA Coated Implants is for restoring chewing function by serving as anchorage for dental restorations.
The Replace HA Coated Implant is both for single-stage or two-stage surgical procedures and cement or screw retained restorations. The Replace HA Coated Implant is intended for immediate placement and function on single tooth and/or multiple tooth applications in good quality bone (type I or type II bone), to restore chewing function. Multiple tooth applications may be splinted with a bar.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The Replace™ HA Coated Implant is to serve as a support for prosthetic devices to restore a patient's chewing function. The available diameters are 3.5 mm, 4.3 mm, 5.0 mm and 6.0 mm with lengths of 10 mm, 13 mm, and 16 mm. The titanium alloy implant has an HA coating on the root form portion to within approximately 2 mm of the top.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Clinical results show that the expanded Indications for Use is as safe and effective as the original Indications for Use.
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.
Not Found
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 text "K022424" written in black ink, with a line drawn underneath it. Below the line is the logo for Nobel Biocare, with the word "Nobel" stacked on top of "Biocare". The logo is also in black ink and has a stylized design.
SEP 2 7 2002
Section 1.7
510(k) Summary
| Establishment
Information | Nobel Biocare USA, Inc.
22715 Savi Ranch Parkway
Yorba Linda, CA 92887
USA
Telephone: (800) 993-8100, ext 7830
FAX: (714) 998-9348 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Richard T. Ross, RAC
Senior Regulatory Affairs Specialist
Telephone: (714) 282-4800, ext. 7830 |
| Proprietary
device name | Replace™ HA Coated Implant (K020646) |
| Classification
name | Endosseous Dental Implant (21 CFR 872.3640) |
| Device
classification | Class III |
| Statement | The information supporting claims of substantial equivalence, as
defined under the Federal Food, Drug, and Cosmetic Act, respecting
safety and effectiveness is summarized below. |
| Device
description | The Replace™ HA Coated Implant is to serve as a support for
prosthetic devices to restore a patient's chewing function. The
available diameters are 3.5 mm, 4.3 mm, 5.0 mm and 6.0 mm with
lengths of 10 mm, 13 mm, and 16 mm. The titanium alloy implant
has an HA coating on the root form portion to within approximately
2 mm of the top. |
| Intended use | The intended use of the Replace HA Coated Implants is for restoring
chewing function by serving as anchorage for dental restorations. |
1
| Indications for
use | The Replace HA Coated Implant is both for single-stage or two-stage
surgical procedures and cement or screw retained restorations. The
Replace HA Coated Implant is intended for immediate placement and
function on single tooth and/or multiple tooth applications in good
quality bone (type I or type II bone), to restore chewing function.
Multiple tooth applications may be splinted with a bar. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
characteristics | The technological characteristics of the Replace HA Coated Implants
remained unchanged. No design modification was made. |
| Performance
data | Clinical results show that the expanded Indications for Use is as safe
and effective as the original Indications for Use. |
| Conclusion | Based on the 510(k) summaries, 510(k) statements and the
information provided herein, we conclude that the expanded
Indications for Use is substantially equivalent to the currently
marketed device under the Federal Food, Drug, and Cosmetic Act. |
Page 17 of 43
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them that resemble water or fabric.
Public Health Service
SEP 2 7 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karon Morell Director, Regulatory Affairs and Quality Assurance Nobel Biocare USA, Incorporated 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K022424
Trade/Device Name: Replace™ HA Coated Implant Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: III Product Code: DZE Dated: July 24, 2002 Received: July 24, 2002
Dear Ms. Morell:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Ms. Morell
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timoth A. Ulatowski Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 1.5
Indications for Use Statement
Page 1 of 1
510(k) Number (if known): Not yet assigned- K022424
Replace™ HA Coated Implant Device Name:
Indications for Use:
The Replace HA Coated Implant is both for single-stage or two-stage surgical procedures and cement or screw retained restorations. The Replace HA Coated Implant is intended for immediate placement and function on single tooth and/or multiple tooth applications in good quality bone (type I or type II bone), to restore chewing function. Multiple tooth applications may be splinted with a bar.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (per 21 CFR 801.109) OR
Over-the-Counter Use Optional Format 1-2-96
Susan Pierre
(Division Sign-Off) (Division Sign-Olf)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
Nobel Biocare USA, Inc. 510(k) Notification Replace™ HA Coated Implant July 2002
Page 12 of 43
510(k) Number