(204 days)
Not Found
No
The summary describes a physical dental abutment and makes no mention of software, algorithms, or AI/ML terms.
No
The device is described as a "pre-manufactured prosthetic component" intended as "an aid in prosthetic rehabilitation," which are characteristics of a prosthetic or reconstructive device, not a therapeutic one that directly treats a disease or condition.
No
Explanation: The device is described as a "pre-manufactured prosthetic component" and an "artificial tooth abutment" used for "prosthetic rehabilitation." Its function is to connect directly to a dental implant, which is a restorative rather than diagnostic purpose. There is no indication that it identifies, detects, or helps diagnose any condition or disease.
No
The device is a physical dental abutment made of zirconia, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as an aid in prosthetic rehabilitation in the anterior region." This describes a device used directly on a patient for a therapeutic or restorative purpose (replacing a tooth).
- Device Description: The description details a "pre-manufactured prosthetic component directly connected to the endosseous dental implant." This is a physical component used in a surgical or dental procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVDs are typically used in laboratories or point-of-care settings to analyze biological samples for diagnostic purposes. This device is a dental prosthetic component used in a clinical setting for patient treatment.
N/A
Intended Use / Indications for Use
NobelActive Zirconia Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation in the anterior region.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
NobelActive Zirconia Abutments are artificial tooth abutments designed to fit and function on the NobelActive Implants. It is an internal hexagonal design similar to the previous SFB (renamed NobelActive) Abutments. The material of construction is the same as the previous Esthetic Zirconia Abutments. The NobelActive Zirconia Abutments differ from the predicate device in trade name and material of construction.
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)
Not Found
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
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
0
510(k) Summary of Safety and Effectiveness 1.4
| Submitted by: | Kam Leung, Ph.D., RAC
Senior Regulatory Affairs Specialist |
|----------------------------------------|------------------------------------------------------------------------------|
| Address: | Nobel Biocare USA LLC
22715 Savi Ranch Parkway
Yorba Linda, CA 92887 |
| Telephone: | (714) 282-4800, ext. 7842 |
| Facsimile: | (714) 282-9023 |
| Date of Submission: | August 1, 2007 |
| Classification Name: | Endosseous dental implant abutment (21 CFR 872.3630) |
| Trade or Proprietary
or Model Name: | NobelActive Zirconia Abutment |
| Legally Marketed Device(s): | SFB & CFB Angled Abutments (K062749)
Esthetic Zirconia Abutment (K031719) |
Device Description:
NobelActive Zirconia Abutments are artificial tooth abutments designed to fit and function on the NobelActive Implants. It is an internal hexagonal design similar to the previous SFB (renamed NobelActive) Abutments. The material of construction is the same as the previous Esthetic Zirconia Abutments. The NobelActive Zirconia Abutments differ from the predicate device in trade name and material of construction.
Indications for Use:
NobelActive Zirconia Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation in the anterior region.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with flowing lines, positioned to the right. Encircling the symbol is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
FEB 22 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nobel Biocare AB C/O Mr. Herbert Crane Director, Global Regulatory Affairs Nobel Biocare USA, LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K072129
Trade/Device Name: NobelActive Zirconia Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 8, 2008 Received: February 11, 2008
Dear Mr. Crane:
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 - Mr. Crane
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 (OS) 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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Shea Runser
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indication for Use
510(k) Number (if known):
Device Name: NobelActive Zirconia Abutment
Indication For Use:
NobelActive Zirconia Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation in the anterior region.
Prescription Use X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Quapp
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Nobel Biocare Traditional 510(K) Not NobelActive Zirconia Abutment August 2007
000008