(86 days)
No
The 510(k) summary describes a dental implant with a design modification (new diameter size) and does not mention any AI/ML capabilities or related performance studies.
Yes
The device is described as an implant used to support prosthetic devices to restore chewing function, indicating it has a therapeutic effect.
No
The device is described as an implant used to support prosthetic devices to restore chewing function, not for diagnosing medical conditions.
No
The device description clearly describes a physical implant made of material and with specific dimensions, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
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. This information is used for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a dental implant, which is a device surgically placed into the bone to support prosthetic teeth. It is a physical implant used in vivo (within the body), not a device used to test samples in vitro (outside the body).
- Intended Use: The intended use is to restore chewing function by supporting artificial teeth in partially edentulous patients. This is a structural and functional restoration, not a diagnostic test.
The description clearly indicates a medical device used for surgical implantation and prosthetic support, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Nobel Direct 3.0mm implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients.
Mandible central and lateral incisors must be splinted if using two or more 3.0mm implants adjacent to one another.
Product codes
III
Device Description
Nobel Biocare's Nobel Direct is a name change of the legally marketed device "Replace" One Piece Implant" (K023952).
Nobel Biocare's Nobel Direct utilizes the same material and fundamental design as the unmodified, predicate device, "Replace" One Piece Implant" (K023952).
Nobel Biocare's Nobel Direct incorporates a design modification by adding an endosseous implant with a diameter of 3.0mm to the existing diameter sizes already in the Nobel Direct product line.
The Nobel Direct 3.0mm implant is restricted for use only in the maxillary lateral position or the mandibular central and lateral incisor position. The Nobel Direct 3.0mm implant/abutment is only available in lengths of 13mm and 15mm. The implant represent the portion of the unit placed in the bone (i.e. threaded portion).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary lateral incisors or the mandibular central and lateral incisors
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
JUL 2 4 2003
Image /page/0/Picture/1 description: The image shows a handwritten string of characters and numbers. The string appears to be "K031345" with a smaller "1.4" written below and slightly to the right of the main string. The characters are written in black ink on a white background, and the handwriting is somewhat rough and uneven.
510(k) Summary of Safety and Effectiveness
| Submitted by: | Elizabeth J. Mason, Sr. Regulatory Affairs Specialist |
|---|---|
| Address: | Nobel Biocare USA Inc. |
| 22715 Savi Ranch Parkway | |
| Yorba Linda, CA 92887 | |
| Telephone: | (714) 282-4800, ext. 7830 |
| Facsimile: | (714) 998-9348 |
| Date of Submission: | April 28, 2003 |
| Classification Name: | Endosseous Dental Implant (21 CFR 872.3640) |
| Trade or Proprietaryor Model Name: | Nobel Direct |
| Legally Marketed Device: | Replace® One Piece Implant (K023952) |
| (also known as > Nobel Direct) |
Device Description:
Nobel Biocare's Nobel Direct is a name change of the legally marketed device "Replace" One Piece Implant" (K023952).
Nobel Biocare's Nobel Direct utilizes the same material and fundamental design as the unmodified, predicate device, "Replace" One Piece Implant" (K023952).
Nobel Biocare's Nobel Direct incorporates a design modification by adding an endosseous implant with a diameter of 3.0mm to the existing diameter sizes already in the Nobel Direct product line.
The Nobel Direct 3.0mm implant is restricted for use only in the maxillary lateral position or the mandibular central and lateral incisor position. The Nobel Direct 3.0mm implant/abutment is only available in lengths of 13mm and 15mm. The implant represent the portion of the unit placed in the bone (i.e. threaded portion).
Indications for Use:
The Nobel Direct 3.0mm implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients.
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three people, with the person in the front reaching out to the other two.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 4 2003
Ms. Elizabeth J. Mason Sr. Regulatory Affairs Specialist Nobel Biocare USA Incorporated 22715 Savi Ranch Parkway, Yorba Linda, California 92887
Re: K031345
Trade/Device Name: Nobel Direct Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: DZE Product Code: III Dated: April 28, 2003 Received: April 29, 2003
Dear Ms. Mason:
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.
2
Page 2 - Ms. Mason
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); 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/
fer
Susan Runner, DDDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Statement of Indications for Use 1.3
Page 1 of 1
510(k) number (if known):
'4031345
Device Name: Nobel Direct
Indications for Use:
morought for 2001
The Nobel Direct 3.0mm implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients.
Mandible central and lateral incisors must be splinted if using two or more 3.0mm implants adjacent to one another.
(Please do not write below this line - Continue on another page if needed.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R.Beitz, DDS for Dr. K. Mulry
510(k) N
(Optional Format 3-10-98)