(32 days)
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No
The document describes a standard dental implant system with mechanical components and does not mention any AI/ML capabilities or related data/performance metrics.
No
The device is a dental implant system, and its components (abutments, protective caps, temporary copings) are intended to support prosthetic reconstructions, protect healing tissue, or serve as a base for temporary restorations. These functions are primarily structural and restorative, not therapeutic in the sense of treating a disease or condition itself.
No
The document describes dental implants, abutments, protective caps, and temporary copings, all of which are prosthetic or support devices, not diagnostic tools. Their intended use is to support prosthetic reconstructions or protect other components, not to diagnose a condition.
No
The device description explicitly states it is an "integrated system of endosseous dental implants, which are designed to support prosthetic devices" and lists physical components like "dental implants, abutments and surgical and prosthetic parts and instruments." This indicates it is a hardware-based medical device system, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The provided description clearly states that this device is a dental implant system, including implants, abutments, protective caps, and temporary copings. These components are physically placed within the patient's mouth to support dental prosthetics.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze biological samples or provide diagnostic information about a patient's health status. Its purpose is structural and restorative.
Therefore, based on the provided information, the Straumann P.004 Dental Implant System is a dental device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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. Temporary Copings are intended to serve as a base for temporary restorations for less than 30 days. 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.
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, temporary copings support a temporary restoration out of occlusion and protective caps protect the abutment during the healing phase.
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
Not Found
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.)
0
1080286
Section H 510(k) SUMMARY
MAR - 7 2008
Applicant's Name and Address 1.
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: February 1, 2008
2. Name of the Device
| Trade Name: | P.004 NC Cementable Abutments
P.004 NC Temporary Copings
P.004 NC Protective Caps |
|----------------------|-----------------------------------------------------------------------------------------|
| Common Name: | Abutment, Dental, Endosseous implants |
| Classification Name: | Abutment, Dental, Endosseous implants |
| Regulation Number: | 21 CFR 872.3630 |
3. Legally Marketed Device to which Equivalence is Claimed (Predicate Device)
P.004 RC Cementable Abutments, K072071 RC Temporary Copings, K072071 RC Protective Caps, K072071
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, temporary copings support a temporary restoration out of occlusion and protective caps protect the abutment during the healing phase.
5. Intended Use of the Device
Abutments are placed into dental implants to provide support for prosthetic restorations such as crowns, bridges and overdentures.
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Abutments can be used in single tooth replacements and multiple tooth restorations. Temporary Copings are intended to serve as a base for temporary restorations for less than 30 days. 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 modified P.004 NC Cementable Abutments, 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.
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 7 2008
Ms. Elaine Alan Regulatory Affairs Specialist Straumann USA (On Behalf Of Institut Straumann AG) 60 Minuteman Road Andover, Massachusetts 01810
Re: K080286 Trade/Device Name: P.004 NC Cementable Abutments P.004 NC Protective Caps P.004 NC Temporary Copings Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 29, 2008 Received: March 3, 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.
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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 (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.
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,
Syurte J. Michie Oms.
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
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INDICATIONS FOR USE STATEMENT
Device Name: P.004 NC Cementable 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.
Device Name: P.004 NC 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 NC Temporary Copings
Indications for Use:
Temporary Copings are intended to serve as a base for temporary restorations for less than 30 days.
× Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Bevice Evaluation (ODE)
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080286
RE: K080286, P.004 NC Cementable Abutments Straumann USA
Supplement 1
February 29, 2008
Proprietary and Confidential
umann OCR
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