(90 days)
Not Found
No
The document describes standard dental implant components and procedures, with no mention of AI or ML technologies.
No
The device components are described as providing support for prosthetic reconstructions, acting as a base for restorations, or protecting other components during healing, which are structural and mechanical functions, not therapeutic.
No
The provided text only describes the components of a dental implant system (abutments, protective caps, copings) that are used for supporting prosthetic reconstructions. There is no mention of these devices being used to diagnose any condition or disease.
No
The device description clearly states it is an "integrated system of endosseous dental implants, which are designed to support prosthetic devices" and lists various physical components like implants, abutments, and surgical/prosthetic parts. This indicates a hardware-based medical device.
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 device is a "Dental Implant System" consisting of implants, abutments, and surgical/prosthetic parts. These are physical devices intended to be surgically implanted and used to support dental restorations.
- Intended Use: The intended use describes the placement of these components within the mouth to support prosthetic reconstructions. This is a mechanical and structural function, not a diagnostic test performed on a biological sample.
The device is a medical device, specifically a dental device, but it does not fit the definition of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
- Device Name: P.004 Abutments
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. The subject abutments are for permanent screw-retained bridges and bar-retained implant-borne dentures. - Device Name: P.004 Protective Caps
Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months. - Device Name: P.004 Permanent Bar and Bridge Copings
Copings are intended to serve as a base for multi-unit bar or bridge restorations. - Device Name: P.004 Temporary Copings
Temporary Copings are intended to serve as a base for temporary restorations for up to 6 months.
Product codes
NHA
Device Description
The Straumann P.004 Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.
Abutments are placed into dental implants to provide support for prosthetic restorations, copings for bars and bridges are used as a base for bar and bridge constructions, temporary copings support a temporary restoration out of occlusion and protective caps protect the abutment during the healing phase.
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)
K894844, K994119, K962023, K051717, K022859, K990342
Reference Device(s)
Not Found
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.)
0
Section I 510(k) SUMMARY
APR 3 0 2008
1. Applicant's Name and Address
Straumann US (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 978-747-2513 Fax Number: 978-747-0023 Contact Person: Elaine Alan Regulatory Affairs Specialist
Date of Submission:
2. Name of the Device
Trade Name: Common Name: Classification Name: Regulation Number:
P.004 RC/NC Bar and Bridge Abutments Line Abutment, Dental, Endosseous implants Abutment, Dental, Endosseous implants 21 CFR 872.3630
3. Legally Marketed Device to which Equivalence is Claimed (Predicate Device)
January 30, 2008
Straumann Octa Abutment, K894844 Straumann synOcta Abutment, K994119 Temporary Copings, K894844 ITI Protective Healing Caps, K962023, K051717 RN synOcta® Gold Copings for Bridges, K022859 RN synOcta® Gold Copings for Bars, K894844 RN synOcta® Titanium Copings for Bars, K990342
4. Description of the Device
The Straumann P.004 Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.
Abutments are placed into dental implants to provide support for prosthetic restorations, copings for bars and bridges are used as a base for bar and bridge constructions, temporary copings support a temporary restoration out of occlusion and protective caps protect the abutment during the healing phase.
1
K0801239
$\underline{2^{c'i^2}}$
5. Intended Use of the Device
Abutments are placed into dental implants to provide support for prosthetic restorations such as crowns, bridges and overdentures, Abutments can be used in single tooth replacements and multiple tooth restorations. The subject abutments are for permanent screw-retained bridges and bar-retained implant-borne dentures. Permanent copings are intended to serve as a base for multi-unit bar or bridge restorations. Temporary Copings are intended to serve as a base for temporary restorations for up to 6 month. Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months.
6. Technological Characteristics
The proposed Bar and Bridge Abutments, Permanent and Temporary Copings and Protective Caps are substantially equivalent to the currently cleared devices. The intended use is identical to the predicate devices. The proposed devices have the same material composition, basic design and fundamental operating principles to the currently cleared devices.
510(k) Submission: RC/NC Bar/Bridge Abutment Line January 30, 2008
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 2008
Ms. Elaine Alan Regulatory Affairs Specialist Straumann USA 60 Minuteman Road Andover, Massachusetts 01810
Re: K080239 Trade/Device Name: P.004 RC/NC Bar and Bridge Abutment Line P.004 Abutments P.004 Protective Caps P.004 Permanent Bar and Bridge Copings P.004 Temporary Copings Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: April 11, 2008 Received: April 21, 2008
Dear Ms. Alan:
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.
3
Page 2 - Ms. Alan
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,
Syrite Y. Michael md.
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
4
INDICATIONS FOR USE STATEMENT
Device Name: P.004 Abutments
Indications for Use:
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. The subject abutments are for permanent screw-retained bridges and bar-retained implant-borne dentures.
Device Name: P.004 Protective Caps
Indications for Use:
Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months.
Device Name: P.004 Permanent Bar and Bridge Copings
Indications for Use:
Copings are intended to serve as a base for multi-unit bar or bridge restorations.
Device Name: P.004 Temporary Copings Indications for Use:
Temporary Copings are intended to serve as a base for temporary restorations for up to 6 months.
× 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) | ||
|---|---|---|
| -- | -------------------------------------------------------- | -- |
| (Division Sign-Off)Division of Anesthesiology, General HospitalInfection Control, Dental Devices | (Division Sign-Off) | Division of Anesthesiology, General Hospital | Infection Control, Dental Devices | ||
|---|---|---|---|---|---|
| (Division Sign-Off) | |||||
| Division of Anesthesiology, General Hospital | |||||
| Infection Control, Dental Devices |
| Page 1 of 1 |
|---|
| 510(k) Submission: RC/NC Bar/Bridge Abutment Line |
| January 30, 2008 |
| 510(k) Number: | K080239 |
|---|---|
| ---------------- | --------- |
| Straumann US Page 5 | |
|---|---|
| -- | --------------------------------- |