(166 days)
No
The 510(k) summary describes a mechanical dental abutment and its accessories. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The changes described relate to sterilization and packaging.
Yes.
The device is intended to restore chewing function, which addresses a health-related condition.
No
The device is described as an abutment, which is a component used in dental implants to support prosthetic restorations. Its purpose is to restore chewing function, not to diagnose a condition.
No
The device description explicitly states that the device includes physical components such as "one-piece straight and angled (17° and 30°) abutments, basal screws and abutment carrier pin." These are hardware components, not software.
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 physical components like abutments, screws, and pins, which are all parts of a dental implant system designed for surgical placement and mechanical function.
- 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 screening.
IVD devices are used to perform tests outside the body on biological samples. This device is a medical device used inside the body for structural support in dental restorations.
N/A
Intended Use / Indications for Use
Straumann® Screw Retained Abutments are indicated to be placed into the implants of the Straumann® Dental Implant System to provide support for prosthetions such as crowns, bridges and bass. 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
Straumann® Screw Retained Abutments include one-piece straight and angled (17° and 30°) abutments, basal screws and abutment carrier pin. The subject device is identical to the primary predicate, K133421, and subsequent premarket notification submissions K141871, K150814 and K151247 with the exception that the subject device will be delivered to the user sterile as opposed to non-sterile and a change in packaging to ensure sterility of the devices.
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): 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.
K141871, K151247, K150814, K130808
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/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right is written in a clear, sans-serif font with the FDA acronym in a blue box.
Straumann USA, LLC (on behalf of Institut Straumann AG) % Jennifer M. Jackson, MS Director, Regulatory Affairs & Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
November 27, 2017
Re: K171757
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: October 25, 2017 Received: October 26, 2017
Dear Jennifer M. Jackson:
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
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 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Mary S. Runner -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Straumann® Screw Retained Abutments
Indications for Use (Describe)
Straumann® Screw Retained Abutments are indicated to be placed into the implants of the Straumann® Dental Implant System to provide support for prosthetions such as crowns, bridges and bass. The final processed devices have the purpose of restoring chewing function. Straumann® Screw Retained Abutments are indicated for screw-retained restorations.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | × |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Straumann® Screw Retained Abutments
510(k) Summary
5 510(k) Summary
5.1 Submitter
Straumann USA, LLC (on behalf of Institut Straumann AG)
60 Minuteman Road
Andover, MA 01810
| Phone Number: | 1-978-747-2614 |
|---|---|
| --------------- | ---------------- |
Fax Number: 1-978-747-0041
Contact Person: Chanrasmey White
Date of Submission: 10/25/2017
5.2 Device
| Trade Name: | Straumann® Screw Retained Abutments |
|---|---|
| Common Name: | Endosseous Dental Implant Abutments |
| Classification Name: | Endosseous Dental Implant Abutments |
| Regulatory Class: | II (21 CFR §872.3630) |
| Product Code: | NHA (21 CFR §872.3630) |
5.3 Predicate Device
Primary Predicate:
-
(K133421) Straumann® Magellan™ Screw Retained Abutment System ●
Reference Predicate: -
(K141871) Straumann Bone Level NC Angled Screw Retained Abutments ●
-
(K151247) Straumann Screw Retained Abutments ●
-
(K150814) Straumann Screw-Retained Abutment .
-
(K130808) Straumann Healing Abutments, Healing Caps, Closure Screws ●
4
Straumann® Screw Retained Abutments
510(k) Summary
Device Description 5.4
Straumann® Screw Retained Abutments include one-piece straight and angled (17° and 30°) abutments, basal screws and abutment carrier pin. The subject device is identical to the primary predicate, K133421, and subsequent premarket notification submissions K141871, K150814 and K151247 with the exception that the subject device will be delivered to the user sterile as opposed to non-sterile and a change in packaging to ensure sterility of the devices.
5.5 Indications for Use
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.
Technoloqical Characteristics 5.6
The proposed Straumann® Screw Retained Abutments intended use, material, fundamental operating principles and overall design are identical to the primary predicate device. The subject device is identical to the primary predicate. K133421, and subsequent premarket notification submissions K141871, K150814 and K151247 with the exception that the subject device will be delivered to the user sterile as opposed to non-sterile and a change in packaging to ensure sterility of the devices. Packaging materials and configuration is equivalent to reference predicate device, Straumann® Straumann Healing Abutments, Healing Caps, Closure Screws, K130808. The technological characteristics of the subject devices are compared to the non-sterile predicate devices (K133421, K141871, K150814 and K151247) in the following table.
5
Straumann® Screw Retained Abutments
510(k) Summary
| Feature | Subject Device | Primary PREDICATE
Device | Reference DEVICE | Reference DEVICE | Reference DEVICE |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | | K133421 | K141871 | K150814 | K151247 |
| Indication | 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. | Straumann® Magellan ™
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. | 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. | 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. | 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. |
| Implant-to-Abutment
Connection | Narrow CrossFit (NC)
Regular CrossFit (RC) | Narrow CrossFit (NC)
Regular CrossFit (RC) | Narrow CrossFit (NC) | Narrow CrossFit (NC) | Narrow CrossFit (NC)
Regular CrossFit (RC) |
| Interface Type | Engaging | Engaging | Engaging | Engaging | Engaging |
| Platform Diameter(s) | NC Straight and Angled: | NC Straight: | NC Angled:
Ø3.5 mm, Ø4.6 mm | NC Straight:
Ø3.5 mm, Ø4.6 mm | NC Angled:
Ø3.5 mm, Ø4.6 mm
RC Angled: |
| Feature | Subject Device | Primary PREDICATE Device | Reference DEVICE | Reference DEVICE | Reference DEVICE |
| K Number | | K133421 | K141871 | K150814 | K151247 |
| | Ø3.5 mm, Ø4.6 mm
RC Straight and Angled:
Ø4.6 mm | Ø3.5 mm, Ø4.6 mm
RC Straight and Angled:
Ø4.6 mm | | | Ø4.6 mm |
| Abutment Angulation(s) | 0°, 17°, 30° | 0°, 17°, 30° | 17°, 30° | 0° | 17°, 30° |
| Gingival Height(s) | NC and RC Straight:
1.0, 2.5 and 4.0 mm
NC and RC Angled:
2.5, 4.0 and 5.5 mm | NC and RC Straight:
1.0, 2.5 and 4.0 mm
RC Angled:
2.5 and 4.0 mm | NC Angled:
2.5 and 4.0 mm | NC Straight:
1.0 mm | NC and RC Angled:
5.5 mm |
| Orientation of Angulation
to Engagement Features | Type A (45°), Type B (0°) | Type A (45°), Type B (0°) | Type A (45°), Type B (0°) | N/A | Type A (45°), Type B (0°) |
| Device Material | Ti-6Al-7Nb titanium alloy | Ti-6Al-7Nb titanium alloy | Ti-6Al-7Nb titanium alloy | Ti-6Al-7Nb titanium alloy | Ti-6Al-7Nb titanium alloy |
| Sterilization | End user receives product
sterilized per Gamma
Irradiation, 25 kGy minimum
Validated per ISO 11137-1
and ISO
11137-2 to an SAL of 10 x
10-6 | End user to sterilize product
per IFU Method: Autoclave
moist heat fractionated
vacuum or gravity
displacement
Conditions: 134°C (273°F)
for 5 minutes | End user to sterilize product
per IFU Method: Autoclave
moist heat fractionated
vacuum or gravity
displacement
Conditions: 134°C (273°F)
for 5 minutes | End user to sterilize product
per IFU Method: Autoclave
moist heat fractionated
vacuum or gravity
displacement
Conditions: 134°C (273°F)
for 5 minutes | End user to sterilize product
per IFU Method: Autoclave
moist heat fractionated
vacuum or gravity
displacement
Conditions: 134°C (273°F)
for 5 minutes |
6
Straumann® Screw Retained Abutments
510(k) Summary
Table 1: Comparison of Subject Devices to non-sterile Predicates