(257 days)
No
The document describes a mechanical dental implant abutment system and does not mention any AI or ML components or functionalities.
No
The device is a dental implant abutment system, a prosthetic component for rehabilitation, not a therapeutic device.
No
The device is described as a prosthetic component and an abutment system for dental implants, used in prosthetic rehabilitation. Its purpose is to support dental prostheses, not to diagnose medical conditions or diseases.
No
The device description clearly outlines a physical, 2-piece dental implant abutment system made of materials like titanium alloy and zirconium oxide, intended for direct connection to an endosseous implant. This 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 "for use in prosthetic rehabilitation," which is a clinical procedure performed directly on a patient, not a test performed on a sample taken from a patient.
- Device Description: The device is a "premanufactured prosthetic component directly connected to an endosseous implant." This describes a physical implantable device used in surgery, not a diagnostic test kit or instrument.
- 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 of diseases or conditions
The device is clearly a dental prosthetic component used in the treatment of patients, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The On1™ device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation.
Product codes
NHA
Device Description
The On1 Concept is a 2-piece dental implant abutment system. It is intended to be used with the Nobel Biocare dental implants that have the internal conical connection. The On1 Concept features the On1 Base that once placed on the dental implant is not intended to be removed. The top portion of the On1 Clinical Screw incorporates threads to accommodate the On1 Healing Cap and On1 Prosthetic Screw allowing the On1 Clinical Screw to remain in position after placement and securing of the On1 Base.
The On1 Concept system includes a healing cap, temporary abutment and esthetic abutments which all fit onto the On1 Base. The esthetic abutments are available in both titanium alloy and zirconium oxide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
The fatigue limit of the On1 Concept was determined using the methods described in ISO 14801. The results of the testing were used to address questions related to substantial equivalence based on difference in design between the subject and predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.)
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three intertwined figures. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W 066-G609 Silver Spring, MD 20993-0002
February 28, 2017
Nobel Biocare AB % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K161655
Trade/Device Name: On1 Concept Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: February 1, 2017 Received: February 2, 2017
Dear Charlemagne Chua:
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 Actinclude 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.
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
1
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.
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. Mary S. Runner - 100 A 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
| DE PARTENT OF FEATH AND HUNN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0170
piration Date: January 31, 2017 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| ndications for Use | es PRA Statement below. |
| 510(k) Number (if known | |
| 166665 | |
| Onl Concept
Device Name | |
| Indications for Use (Describe | |
| it it belies is a premiument pirestly compensed to an endossous in and it it | |
| intended for use in prosthetic rehabilitation. | |
| | |
| of Use (Select one or both, as applicable, | |
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510(k) Summary
I. SUBMITTER
Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden
Submitted by: Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887
Contact Person: Charlemagne Chua. Senior Requlatory Affairs Manager E-mail: Charlemagne.chua@nobelbiocare.com Phone: (714) 282-4800 x 7830 Fax: (714) 998-9348
Date Prepared: February 27, 2017
II. DEVICE
Name of Device: On1 Concept Common or Usual Name: Endosseous Dental Implant Abutment Classification Name: Endosseous Dental Implant (21 CFR 872.3630) Requlatory Class: II Product Code: NHA
III.PREDICATE DEVICE
Primary Predicate NobelProcera Angulated Screw Channel Abutment Conical Connection (K132746)
Reference Predicate NobelActive Wide Platform (WP) (K133731)
IV. DEVICE DESCRIPTION
The On1 Concept is a 2-piece dental implant abutment system. It is intended to be used with the Nobel Biocare dental implants that have the internal conical connection. The On1 Concept features the On1 Base that once placed on the dental implant is not intended to be removed. The top portion of the On1 Clinical Screw incorporates threads to accommodate the On1 Healing Cap and On1
4
Prosthetic Screw allowing the On1 Clinical Screw to remain in position after placement and securing of the On1 Base.
The On1 Concept system includes a healing cap, temporary abutment and esthetic abutments which all fit onto the On1 Base. The esthetic abutments are available in both titanium alloy and zirconium oxide.
V. INDICATIONS FOR USE
The On1™ device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation.
VI. Comparison of Technological Characteristics
| Technological
| characteristics | Subject Device | Primary Predicate | Reference Predicate | |
|---|---|---|---|---|
| On1 Concept | NobelProcera Angulated Screw | |||
| Channel Abutment Conical | ||||
| (K132746) | NobelActive Wide | |||
| Platform (WP) | ||||
| (K133731) | ||||
| Design Features | Compatible | |||
| Implant | ||||
| Platform | Nobel Biocare Internal Conical | |||
| Connection |
- Narrow Platform (NP)
- Regular Platform (RP)
- Wide Platform (WP) | Nobel Biocare Internal Conical
Connection - Narrow Platform (NP)
- Regular Platform (RP) | Nobel Biocare Internal
Connection / Internal
Hex - Wide Platform (WP) |
| | Device
Material | On1 Base, Temporary
Abutment, On1 Healing Cap,
Esthetic Abutment Titanium,
Clinical Screws and Prosthetic
Screws - Titanium vanadium
alloy (ASTM F1472, ASTM
F136)
On1 Esthetic Abutment
Zirconia – Y-TZP zirconium
oxide (ISO 6872, ISO 13356) | Abutment base and clinical
screw - Titanium vanadium
alloy (ASTM F1472, ASTM
F136)
Abutment post – Y-TZP
zirconium oxide (ISO 6872, ISO
- | Titanium vanadium
alloy (ASTM F1472,
ASTM F136) |
| | Abutment
Design | 2 piece (base placed either at
time of implant placement or
with final abutment)
Abutment shape fixed | 2 piece (base placed with final
abutment)
Abutment shape personalized | Patient Specific Design |
| | Abutment
height | Combined base and post
height
Temporary Abut – 8.3, 9.0 mm
Esthetic Abut Ti – 8.2, 9.0 mm
Esthetic Abut Zi - 8.2, 9.0 mm | Not applicable - abutment
shape personalized | Not applicable -
abutment shape
personalized |
| | Abutment
width | At base
4.8, 5.3, 6.5 mm | Not applicable - abutment
shape personalized | Not applicable -
abutment shape
personalized |
| | Abutment
Angulation | No abutment angulation | Variable screw channel and
abutment angulation based on
personalized design. | Not applicable -
abutment shape
personalized |
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| Technological
| characteristics | Subject Device | Primary Predicate | Reference Predicate |
|---|---|---|---|
| Intended use | The On1™ devices are | ||
| intended for use in the field of | |||
| dentistry. They are intended to | |||
| be used in the upper or lower | |||
| jaw for supporting tooth | |||
| replacements to restore | |||
| chewing function and | |||
| esthetics. | |||
| The On1™ esthetic abutments | |||
| in combination with the On1™ | |||
| Base on Nobel Biocare | |||
| Conical Connection | |||
| endosseous implants are | |||
| indicated for single-unit | |||
| cement retained restorations. | Nobel Biocare's NobelProcera | ||
| ASC Abutment Zirconia is a | |||
| customized endosseous dental | |||
| abutment. The abutment | |||
| attaches directly to the dental | |||
| implants and provides a | |||
| platform for restoration. The | |||
| NobelProcera ASC Abutment | |||
| Zirconia is designed and made | |||
| individually to fit the individual | |||
| requirements for each patient. | |||
| The NobelProcera ASC | |||
| Abutment Zirconia is made out | |||
| of Zirconia and is delivered with | |||
| a titanium adapter. | Not Applicable – | ||
| reference predicate to | |||
| support abutment for | |||
| use with Wide platform | |||
| implants. | |||
| Indication for | |||
| Use | The On1™ device is a | ||
| premanufactured prosthetic | |||
| component directly connected | |||
| to an endosseous implant and | |||
| it is intended for use in | |||
| prosthetic rehabilitation. | The NobelProcera Angulated | ||
| Screw Channel Abutment | |||
| Conical Connection are | |||
| premanufactured prosthetic | |||
| components directly connected | |||
| to endosseous dental implants | |||
| and are intended for use as an | |||
| aid in prosthetic rehabilitation. | Not Applicable – | ||
| reference predicate to | |||
| support abutment for | |||
| use with Wide platform | |||
| implants. |
Analysis of Differences Between Subject Device and Predicate
The On1 Concept and predicate NobelProcera Angulated Screw Channel Conical Connection (K132746) are both two piece endosseous dental implant abutments intended to fit the Nobel Biocare internal conical connection dental implants.
The On1 Concept base is designed to be placed either when the dental implant is placed or with the final abutment. Once placed on the dental implant the On1 Base is not intended to be removed. The predicate NobelProcera Angulated Screw Channel Conical Connection (K132746) base is intended to adapt the abutment post to the internal conical connection implant and is placed along with the post when the definitive abutment is placed.
The On1 Concept components are all fixed design components. The abutments do not have any angulation built in. The predicate NobelProcera Angulated Screw Channel Conical Connection (K132746) abutments are individually shaped and can be angulated.
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Summarv:
The design differences between the subject and predicate devices were evaluated through comparative performance testing. The documentation submitted in the premarket notification demonstrates that the On1 Concept is substantially equivalent to the predicate devices.
VII. PERFORMANCE DATA
Summary of Non-Clinical Testing:
Since the subject device does not represent a new worst case, data from the predicate device was leveraged in the following aspects of the 510(k).
- Sterile Device Information
- o The sterilization method for the subject device provided sterile is the same as the predicate. The sterilization method is Gamma radiation and has been validated in accordance with ANSI/AAMI/ISO 11137. Therefore, no additional testing was required.
- o The sterilization methods for the subject devices provided non-sterile and to be end user sterilized are pre-vacuum and gravity moist heat sterilization and have been validated in accordance with ANSI/AAMI/ISO 17665-1.
- Device Packaging
- o The packaging for the subject device is the same as the predicate. This is a thermoform tray with peel top lid. Therefore, no additional testing was required.
- Shelf Life -
- The packaging for the subject device is the same as the predicate and o is labeled with a 3-year expiration date. Real time aging was used to determine the expiration dating. Therefore, no additional testing was required.
- Biocompatibility -
- The subject device is manufactured from the same material using the o same manufacturing method as the predicate, has the same intended use, and the same patient contact type and duration. Therefore, no additional testing was required.
The fatigue limit of the On1 Concept was determined using the methods described in ISO 14801. The results of the testing were used to address questions related to substantial equivalence based on difference in design between the subject and predicate devices.
VIII. CONCLUSIONS
The On1 Concept was evaluated for substantial equivalence using standard and/or comparative testing. In cases where the On1 Concept could be shown to not represent a worst-case with respect to the predicates, data from these predicate
7
devices was leveraged to support the subject device. Based on technological characteristics and non-clinical test data included in this submission, the On1 Concept has been shown to be substantially equivalent to the NobelProcera Angulated Screw Channel Conical Connection Abutment (K132746).