(108 days)
Not Found
Not Found
No
The description focuses on the mechanical design and material of a dental abutment, with no mention of AI or ML capabilities.
No.
The device is a dental implant component used to support prosthetic restorations, not to treat or cure a disease or condition.
No
This device is an angled abutment for dental implants, used to support prosthetic restorations and correct prosthetic angulation. It is a restorative component, not a device used to diagnose a medical condition.
No
The device description clearly states it is a physical component (angled abutment) made of titanium alloy, intended for surgical implantation. It does not describe any software functionality.
Based on the provided text, 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: The description clearly states that the XP1 Angled Abutment is a physical device made of titanium alloy intended to be placed into a dental implant to support prosthetic restorations. It is a surgical implant component.
- Intended Use: The intended use is for supporting dental restorations in the mouth, not for analyzing biological samples.
The device is a medical device, specifically a dental implant component, but it does not fit the definition of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The XP1 Angled Abutment is intended for use in conjunction with the XP1 Dental Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations. The angled abutment is indicated in cases where angle correction is required.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The XP1 15° Angled Abutment is intended to be placed into a dental implant to support prosthetic restorations in partially or fully edentulous mandibles and maxillae. The angled abutment can be used for single or multiple-unit restorations and is intended for cement-retained crowns. The angled abutment is used to correct the prosthetic anqulation of implants that are placed off-axis to the occlusal load.
The distal end of the angled abutment has a hex and taper design that engages the mating internal hex and taper of the implant. In addition, the angled abutment has a screw channel with a screw thread at the distal end through which an abutment screw is used to screw the abutment into the implant.
The XP1 Angled Abutment and the abutment screws are machined from titanium allov (Ti-6AL-4V ELI) conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surqical Implant Applications.
The device is provided non-sterile to the user in medical grade packaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibles and maxillae
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.
Not Found
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.)
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Additional Information: K090397
XP1 Angled Abutments
JUN - 5 2009
510(k) Summary
Keystone Dental. Inc. XP1® Angled Abutments
ADMINISTRATIVE INFORMATION
Manufacturer Name:
Keystone Dental, Inc. 144 Middlesex Turnpike Burlington, MA 01803 Telephone: 1 (781) 272-9272 Fax: 1 (781) 272-9972
Official Contact:
Carolyn Bitetti SVP, Quality/Regulatory Keystone Dental. Inc. Direct Line: 781-328-3305 Fax: 781-272-9972 Email: cbitetti@keystonedental.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Name: Classification Regulations: XP1 Angled Abutments Abutment for dental implant Endosseous dental implant abutment (21 CFR 872.3630), Class II NHA
Product Codes
DEVICE CLASSIFICATION PANEL
The Classification Panel for these devices is the Dental Products Panel: the devices are reviewed by the Dental Devices Branch.
INTENDED USE
The XP1 Angled Abutment is intended for use in conjunction with the XP1 Dental Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations. The angled abutment is indicated in cases where angle correction is required.
1
DEVICE DESCRIPTION
The XP1 15° Angled Abutment is intended to be placed into a dental implant to support prosthetic restorations in partially or fully edentulous mandibles and maxillae. The angled abutment can be used for single or multiple-unit restorations and is intended for cement-retained crowns. The angled abutment is used to correct the prosthetic anqulation of implants that are placed off-axis to the occlusal load.
The distal end of the angled abutment has a hex and taper design that engages the mating internal hex and taper of the implant. In addition, the angled abutment has a screw channel with a screw thread at the distal end through which an abutment screw is used to screw the abutment into the implant.
The XP1 Angled Abutment and the abutment screws are machined from titanium allov (Ti-6AL-4V ELI) conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surqical Implant Applications.
The device is provided non-sterile to the user in medical grade packaging.
EQUIVALENCE TO ORIGINAL CLEARED PRODUCT
Keystone Dental, Inc. has demonstrated that, for the purposes of FDA's regulation of medical devices, the XP1 Angled Abutment is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three wing-like shapes, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. The text is in all capital letters and is evenly spaced around the circle.
Public Health Service
JUN - 5 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Carolyn Bitetti Senior Vice President, Quality/Regulatory Keystone Dental, Incorporated 144 Middlesex Turnpike Burlington, Masachussets, 01803
Re: K090397
Trade/Device Name: XP1 Angled Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 14, 2009 Received: May 15, 2009
Dear Ms. Bitetti:
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 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. Bitetti
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/cdrh/comp/ 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Funner
Susan Runner, D.D.S., MA Acting Division 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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XP1 Angled Abutments
Indications for Use
510(k) Number (if known): K090397
Device Name:
XP1® Angled Abutments
Indications for Use:
The XP1 Angled Abutment is intended for use in conjunction with the XP1 Dental Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations. The angled abutment is indicated in cases where angle correction is required.
Kevin Nale fr MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K090397 510(k) Number:
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)