(81 days)
Not Found
No
The summary describes a dental implant and abutment, focusing on mechanical properties and intended use. There is no mention of AI or ML technology.
Yes
The device is used to restore chewing function in partially edentulous patients, which is a therapeutic purpose.
No
Explanation: The device description and intended use clearly state that the NobelActive 3.0mm implant and GoldAdapt Abutment are used to support prosthetic devices to restore chewing function. There is no mention of the device being used to diagnose a medical condition or disease.
No
The device description explicitly states it is an abutment made of a gold alloy, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the device is a dental implant and abutment used to support prosthetic teeth in the oral cavity to restore chewing function. This is a surgical and prosthetic device, not a diagnostic test performed on a sample.
- Lack of Diagnostic Information: The document does not mention any diagnostic purpose, analysis of biological samples, or detection of any medical condition.
Therefore, the NobelActive 3.0mm implant and GoldAdapt Abutment are not IVDs. They are medical devices used for surgical and prosthetic purposes in dentistry.
N/A
Intended Use / Indications for Use
The NobelActive 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. The NobelActive 3.0 implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied.
The NobelActive 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. The NobelActive 3.0 implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The NobelActive 3.0 GoldAdapt Abutment is an abutment intended to be used with the Nobel Biocare NobelActive 3.0 implant system. The abutments are made of a gold alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral Cavity
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)
Non-clinical test data was used to support the decision of substantial equivalence. Non-clinical testing consisted of performance of fatigue testing in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. The testing indicates that the device is strong enough to withstand the anticipated forces.
No clinical testing was performed. Non-clinical test data was used to support the decision of safety and effectiveness.
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
Kl b2259
| Submitted by: | Herbert Crane
Director, Global Regulatory Affairs | OCT 28 2011 |
|----------------------------------------|----------------------------------------------------------------------------|-------------|
| Address: | Nobel Biocare USA LLC
22715 Savi Ranch Parkway
Yorba Linda, CA 92887 | |
| Telephone: | (714) 282-5074 | |
| Facsimile: | (714) 998-9348 | |
| Date of Submission: | August 5, 2011 | |
| Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) | |
| Product Code: | NHA | |
| Trade or Proprietary
or Model Name: | NobelActive 3.0 GoldAdapt Abutment | |
| Legally Marketed Devices: | Nobel Biocare -- NobelActive 3.0 (K102436) | |
Device Description:
The NobelActive 3.0 GoldAdapt Abutment is an abutment intended to be used with the Nobel Biocare NobelActive 3.0 implant system. The abutments are made of a gold alloy.
Nobel Biocare - NobelActive GoldAdapt Abutment (K083100)
Indications for Use:
The NobelActive 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. The NobelActive 3.0 implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied.
Non-Clinical Testing:
Non-clinical test data was used to support the decision of substantial equivalence. Non-clinical testing consisted of performance of fatigue testing in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. The testing indicates that the device is strong enough to withstand the anticipated forces.
Clinical Testing;
No clinical testing was performed. Non-clinical test data was used to support the decision of safety and effectiveness.
Conclusions:
The testing indicates that the abutments are substantially equivalent to the identified predicates.
Nobel Biocare Special 510(k) Notification NobelActive 3.0 GoldAdapt Abutment August 2011
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510(k) Summary of Safety and Effectiveness 1.4
Substantial Equivalence Comparison to Predicate Devices
| CHARACTERISTIC | PREDICATE
NobelActive GoldAdapt Abutment
(K083100) | PREDICATE
NobelActive 3.0
(K102436) | CANDIDATE
NobelActive 3.0 GoldAdapt
Abutment |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | NobelActive | NobelActive | NobelActive |
| Anatomical Site | Oral Cavity | Oral Cavity | Oral Cavity |
| Abutment Material | Gold Alloy | Titanium Vanadium Alloy | Gold Alloy |
| Abutment angulation | 0 deg | 0 deg | 0 deg |
| Implant/Abutment
Connection | Internal Hex | Internal Hex | Internal Hex |
| Indications for Use | Nobel Biocare's NobelActive implants
are endosseous implant intended to
be surgically placed in the bone of the
upper or lower jaw arches to provide
support for prosthetic devices, such
as an artificial tooth, in order to
restore patient esthetics and chewing
function. Nobel Biocare's NobelActive
implants are indicated for single or
multiple unit restorations in splinted or
non-splinted applications. Nobel
Biocare's NobelActive implants may
be placed immediately and put into
immediate function provided that initial
stability requirements detailed in the
manual are satisfied. | The NobelActive 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. The NobelActive 3.0 implants
may be put into immediate function
provided that stability requirements
detailed in the manual are satisfied. | The NobelActive 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. The
NobelActive 3.0 implants may be put
into immediate function provided
that stability requirements detailed in
the manual are satisfied. |
Nobel Biocare Special 510(k) Notification
NobelActive 3.0 GoldAdapt Abutment
August 2011
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 8 2011
Nobel Biocare AB C/O Mr. Herbert Crane Director, Global Regulatory Affairs Nobel Biocare USA LLC 22715 Savi Ranch Parkwav Yorba Linda, California 92887
Re: K112259
Trade/Device Name: NobelActvie 3.0 GoldAdapt Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 27, 2011 Received: September 28, 2011
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. 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.
lf 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.
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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); medical device reporting (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours.
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/1 description: The image shows the word "Kiiasa" written in cursive. The letters are connected and slanted. The word is written in black ink on a white background.
510(k) Number (if known):
Device Name: NobelActive 3.0 GoldAdapt Abutment
Indications For Use:
The NobelActive 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. The NobelActive 3.0 implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rumer
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number