(134 days)
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No
The document describes dental implant abutments and their intended use and materials. There is no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The device is used in prosthetic restorations with implants, which are considered therapeutic interventions to restore function and form.
No
The device is an endosseous dental implant abutment used for prosthetic restorations, not for diagnosing medical conditions.
No
The device description explicitly states that the device is an "endosseous dental implant abutment" and is "machined from Titanium Alloy". This indicates a physical hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as being used for prosthetic restorations with dental implants, specifically bridges or bar overdentures. This is a mechanical/structural application within the body.
- Device Description: The description details the physical characteristics of the abutments, their materials (Titanium Alloy), and how they connect to implants. This aligns with a medical device used for structural support.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
The device is a dental implant abutment, which is a type of medical device used in reconstructive dentistry.
N/A
Intended Use / Indications for Use
The angled XiVE® MP and angled ANKYLOS® Balance Base Abutments are indicated for use in prosthetic restorations with XiVE® and ANKYLOS® implants, respectively, and bridges or bar overdentures using a minimum of 2 implants. In edentulous jaws, immediate loading is possible using a minimum of 4 implants. Implants may be tilted up to 45°. When used with angulations between 30°and 45° in edentulous arch, a minimum of four implants must be used and splinted.
The straight FRIADENT® MP and straight ANKYLOS® Balance Base Abutments are implants, respectively, and bridges or bar overdentures using a minimum of 2 implants. In edentulous jaws, immediate loading is possible using a minimum of 4 implants.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Angled XiVE® MP and ANKYLOS® Balance Base Abutment are endosseous dental implant abutments which provide a platform for prosthetic restoration with bridges or bar constructions in conjunction with XiVE and ANKYLOS® implants. The abutments are provided with an angulation of 15° and 30° at gingival heights ranging from 2.0mm - 5.0 mm for angled XiVE® MP abutments and from 3.0mm - 4.5mm for angled ANK YLOS® Balance Base abutments, respectively. The angled ANK YLOS® BalanceBase Abutments are offered in 3.45mm diameter (compatible with all ANKYLOS® implants). The angled XiVE® MP Abutments are offered in diameters ranging from 3.4mm (compatible with 3.4mm diameter XIVE® implants) to 3.8mm (compatible with XiVE® implants of 3.8mm - 5.5mm diameter). The abutments are connected to the corresponding implants by a central screw which mates with the internal thread of the implant. The abutments and the abutment screws are machined from Titanium Alloy (Ti6AL4V ELI) conforming to ASTM F 136 (Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial Alloy for Surgical Implant Applications).
The Angled XiVE® MP and ANKYLOS® Balance Base Abutments facilitate the SmartFixTM treatment concept in which the angled abutments are used in combination with straight abutments on a of minimum four (4) implants (with two posterior implants placed at an angle of up to 45° in the posterior region) to support prosthetic restorations.
In addition to the introduction of the Angled XiVE® MP and ANK YLOS® Balance Base Abutments, a modification to the indications for use statements of the currently marketed straight FRIADENT® MP and straight ANKYLOS® Balance Base Abutments is implemented as part of this premarket notification.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data.
Representative fatigue data from testing is included and the results support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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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SECTION 5. 510(k) SUMMARY
Angled XiVE® MP and ANKYLOS® Balance Base Abutments
DEC 1 1 2012
1. Submitter Information:
DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405
| Contact Person: | Helen Lewis |
|---|---|
| Telephone Number: | 717-849-4229 |
| Fax Number: | 717-849-4343 |
November 2, 2012 Date Prepared:
- Device Name: 2.
- Proprietary Name: .
Angled XiVE® MP and ANKYLOS® Balance Base Abutments
Endosseous dental implant abutment
- Classification Name: CFR Number: .
- Device Class: .
- Product Code: NHA .
3. Predicate Device:
.
- Angled Multi-Unit Abutments cleared in K050406 (NOBELSPEEDY™ � Implants)
- Straight ANKYLOS® Balance Base Abutments cleared in K073075 .
872.3630
II
- (FRIADENT Implant Systems) .
- Straight FRIADENT® MP Abutments cleared in K994174 (FRIALIT-2® . MH-2 ABUTMENT)
Description of Device: 4.
The Angled XiVE® MP and ANKYLOS® Balance Base Abutment are endosseous dental implant abutments which provide a platform for prosthetic restoration with bridges or bar constructions in conjunction with XiVE and ANKYLOS® implants. The abutments are provided with an angulation of 15° and 30° at gingival heights ranging from 2.0mm - 5.0 mm for angled XiVE® MP abutments and from 3.0mm - 4.5mm for angled ANK YLOS® Balance Base abutments, respectively. The angled ANK YLOS® BalanceBase Abutments are offered in 3.45mm diameter (compatible with all ANKYLOS® implants). The angled XiVE® MP Abutments are offered in diameters ranging from 3.4mm (compatible with 3.4mm diameter XIVE® implants) to 3.8mm (compatible with XiVE® implants of 3.8mm - 5.5mm diameter). The abutments are connected to the corresponding implants by a central screw which mates with the internal thread of the implant. The abutments and the abutment screws are machined from Titanium Alloy (Ti6AL4V ELI) conforming to ASTM F 136 (Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial Alloy for Surgical Implant Applications).
Premarket Notification
Angled XiVE* MP and ANKYLOS* Balance Base Abutment
DENTSPLY International
1
The Angled XiVE® MP and ANKYLOS® Balance Base Abutments facilitate the SmartFixTM treatment concept in which the angled abutments are used in combination with straight abutments on a of minimum four (4) implants (with two posterior implants placed at an angle of up to 45° in the posterior region) to support prosthetic restorations.
In addition to the introduction of the Angled XiVE® MP and ANK YLOS® Balance Base Abutments, a modification to the indications for use statements of the currently marketed straight FRIADENT® MP and straight ANKYLOS® Balance Base Abutments is implemented as part of this premarket notification.
న. Indications for Use:
The angled XiVE® MP and angled ANKYLOS® Balance Base Abutments are indicated for use in prosthetic restorations with XiVE® and ANKYLOS® implants, respectively, and bridges or bar overdentures using a minimum of 2 implants. In edentulous jaws, immediate loading is possible using a minimum of 4 implants may be tilted up to 45°. When used with angulations between 30°and 45° in edentulous arch, a minimum of four implants must be used and splinted.
The straight FRIADENT® MP and straight ANKYLOS® Balance Base Abutments are indicated for use in prosthetic restorations with XiVE®, FRIALIT® and ANKYLOS® implants, respectively, and bridges or bar overdentures using a minimum of 2 implants. In edentulous jaws. immediate loading is possible using a minimum of 4 implants.
6. Description of Safety and Substantial Equivalence:
Technological Characteristics.
The material used for the Angled XiVE® MP and ANKYLOS® Balance Base Abutments, Ti6Al4V, is the same Titanium Alloy material as is used in the legally marketed predicate device. The proposed devices are similar in terms of design, angulations, sizes, indications for use and incorporate the same technological characteristics as the predicate devices.
In order to assure safety of the Angled XiVE® MP and ANKYLOS® Balance Base Abutment, a failure mode, effect and criticality analysis has been performed. There were no unacceptable risks regarding the function of the Angled XiVE® MP and ANKYLOS® Balance Base Abutments.
Non-Clinical Performance Data.
Representative fatigue data from testing is included and the results support substantial equivalence.
Conclusion as to Substantial Equivalence:
Based on the comparison of the indications for use, the technological characteristics and the nonclinical testing it can be concluded that the Angled XiVE® MP and ANK YLOS® Balance Base Abutment are substantially equivalent to the predicate devices.
Angled XiVE* MP and ANKYLOS* Balance Base Abutment Premarket Notification DENTSPLY International
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is arranged on a single line and appears to be a title or heading. The font is a serif typeface, and the overall impression is one of official documentation or signage.
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 11, 2012
Ms. Helen Lewis Director. Corporate Regulatory Affairs DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60W YORK PA 17404
Re: K122268
Trade/Device Name: Angled XiVE® MP and ANKYLOS® Balance Base Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 2, 2012 Received: November 13, 2012
Dear Ms. Lewis:
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.
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.
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Page 2 - Ms. Lewis
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 or any I vith 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/ucm115809.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.goy/MedicaiDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kwame O. Ulmer
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and
Dental Devices
Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
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SECTION 4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K122268
Device Name: Angled XiVE® MP and ANKYLOS® Balance Base Abutments
Indications for Use:
The angled XiVE® MP and angled ANKYLOS® Balance Base Abutments are indicated for use in prosthetic restorations with XiVE® and ANKYLOS® implants, respectively, and bridges or bar overdentures using a minimum of 2 implants. In edentulous jaws, immediate loading is possible using a minimum of 4 implants. Implants may be tilted up to 45°. When used with angulations between 30°and 45° in edentulous arch, a minimum of four implants must be used and splinted.
The straight FRIADENT® MP and straight ANKYLOS® Balance Base Abutments are implants, respectively, and bridges or bar overdentures using a minimum of 2 implants. In edentulous jaws, immediate loading is possible using a minimum of 4 implants.
Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
2012.12.05 Susan Runner DDS, MA -12:56:50 -05'00'
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital Division of Control, Dental Devices
510(k) Number: