(27 days)
Not Found
No
The document describes a dental abutment, a mechanical component, and there is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device restores chewing function, which is a functional restoration, not a therapeutic treatment for a disease or condition.
No
The device is described as providing support for prosthetic reconstructions to restore chewing function, which is a therapeutic rather than a diagnostic purpose.
No
The device description clearly states it is a line extension of physical abutments, which are hardware components used in dental implants. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "provide support for prosthetic reconstructions such as crowns, bridges and bars" and "restoring chewing function." This describes a device used in vivo (within the body) for structural support and functional restoration.
- Device Description: The description details a physical implant component (abutment) that is placed into a dental implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly designed for direct use within the patient's mouth.
N/A
Intended Use / Indications for Use
The Straumann® Screw Retained Abutments are indicated to be placed into the implants of the Straumann® Dental Implant System to provide support for prosthetic reconstructions such as crowns, bridges and bars.
The final processed devices have the purpose of restoring chewing function.
Straumann® Screw Retained Abutments are indicated for screw-retained restorations.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The proposed Straumann® NC Angled Screw Retained Abutments are a line extension of the NC Straight and RC Straight and Angled Screw Retained Abutments cleared to market per premarket notification submission K133421.
The Straumann® NC Angled Screw Retained Abutments include 17° and 30° abutments. This is consistent with the RC Angled Screw Retained Abutments cleared to market per premarket notification submission K133421.
The subject devices are produced from titanium-6aluminum-7niobium alloy (TAN) conforming to ISO 5832-11. This is the same material as for the predicate abutments cleared to market per premarket notification submission K133421.
The proposed Straumann® NC Angled Screw Retained Abutments are manufactured using precision machining systems from solid material (i.e. one-piece construction). All technological characteristics of the subject devices are the same as for devices as shown in the table below.
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)
Per Guidance for Industry and FDA Staff - Class II Special Performance Data: Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments dated May 12, 2004, the substantial equivalence of the subject device(s) are satisfactorily addressed via bench studies. Dynamic fatigue test data consistent with FDA guidance and ISO 14801 have been referenced in support of this submission.
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.
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.)
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2014
Straumann USA, Limited Liability Company Mr. Christopher Klaczyk Director of Regulatory Affairs & Clinical Research 60 Minuteman Road Andover, MA 01810
Re: K141871
Trade/Device Name: Straumann® Screw Retained Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: July 9, 2014 Received: July 11, 2014
Dear Mr. Klaczyk:
This letter corrects our substantially equivalent letter of August 7, 2014.
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.
1
Page 2 - Mr. Klaczyk
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 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" (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 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 vours.
Mary S. Runner -S
Erin I. Keith Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
4. Indications For Use
510(k) Number (if known): K141871
Straumann® Screw Retained Abutments Device Name:
Indications for Use:
The Straumann® Screw Retained Abutments are indicated to be placed into the implants of the Straumann® Dental Implant System to provide support for prosthetic reconstructions such as crowns, bridges and bars.
The final processed devices have the purpose of restoring chewing function.
Straumann® Screw Retained Abutments are indicated for screw-retained restorations.
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)
Sheena A. Green-S 2014.08.07 13:44:29-04'00'
3
5. 510(k) Summary
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)
60 Minuteman Road
Andover, MA 01810
Registration No .: 1222315 Owner/Operator No .: 9005052 | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Christopher Klaczyk
Director of Regulatory Affairs and Clinical Research
Tel.: (978) 747-2575 | |
| Date Prepared: | July 9, 2014 | |
| Product Code(s): | NHA (21 CFR 872.3630) | |
| Device Class: | (21 CFR 872.3630)
II | |
| Classification Panel: | Dental | |
| Classification Name: | Endosseous dental implant abutments (21 CFR 872.3630) | |
| Proprietary Name: | Straumann® Screw Retained Abutments | |
| Predicate Device(s): | Straumann® Magellan Abutment System (K133421)
● | |
| Device Description: | The proposed Straumann® NC Angled Screw Retained
Abutments are a line extension of the NC Straight and RC
Straight and Angled Screw Retained Abutments cleared to
market per premarket notification submission K133421. | |
| | The Straumann® NC Angled Screw Retained Abutments
include 17° and 30° abutments. This is consistent with the RC
Angled Screw Retained Abutments cleared to market per
premarket notification submission K133421. | |
| Intended Use: | The Straumann® Screw Retained Abutments are indicated to be
placed into the implants of the Straumann® Dental Implant
System to provide support for prosthetic reconstructions such as
crowns, bridges and bars. | |
| | The final processed devices have the purpose of restoring
chewing function. | |
| | Straumann® Screw Retained Abutments are indicated for
screw-retained restorations. | |
| Materials: | The subject devices are produced from titanium-6aluminum-
7niobium alloy (TAN) conforming to ISO 5832-11. This is the
same material as for the predicate abutments cleared to market
per premarket notification submission K133421. | |
| Technological
Characteristics: | The proposed Straumann® NC Angled Screw Retained
Abutments are manufactured using precision machining
systems from solid material (i.e. one-piece construction). All
technological characteristics of the subject devices are the same
as for devices as shown in the table below. | |
4
| Feature | Subject Devices
NC Angled Screw Retained
Abutments | Predicate Devices
Magellan Abutment System
K133421 |
|-----------------------------------------------------|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Implant-to-Abutment
Connection | Narrow CrossFit (NC) | Narrow CrossFit (NC)
Regular CrossFit (RC) |
| Interface Type | Engaging | Engaging |
| Platform Diameter(s) | NC: Ø4.6 mm | NC: Ø3.5 mm, Ø4.6 mm
RC: Ø4.6 mm |
| Abutment Angulation(s) | NC: 17°, 30° | NC: 0°
RC: 0°, 17°, 30° |
| Gingival Height(s) | NC Angled: 2.5 mm, 4.0 mm | NC Straight: 1.0, 2.5 and 4.0 mm
RC Straight: 1.0, 2.5 and 4.0 mm
RC Angled: 2.5 and 4.0 mm |
| Orientation of Angulation
to Engagement Features | NC: Type A (45°), Type B (0°) | NC: N/A
RC: Type A (45°), Type B (0°) |
| Material | Ti-6Al-7Nb titanium alloy | Ti-6Al-7Nb titanium alloy |
| Primary Package | Medical grade polyethylene blister
with a sealing lid | Medical grade polyethylene blister
with a sealing lid |
| Sterilization | Non-sterile; intended for terminal
sterilization via moist heat
(autoclave) | Non-sterile; intended for terminal
sterilization via moist heat
(autoclave) |
Per Guidance for Industry and FDA Staff - Class II Special Performance Data: Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments dated May 12, 2004, the substantial equivalence of the subject device(s) are satisfactorily addressed via bench studies. Dynamic fatigue test data consistent with FDA guidance and ISO 14801 have been referenced in support of this submission.
- Based upon our assessment of the design and applicable Conclusions: performance data, the subject devices have been determined to be substantially equivalent to the identified predicate devices.