(112 days)
No
The summary describes physical dental devices (healing abutments, caps, screws) used for protecting implants and managing soft tissue during healing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on sterilization, biocompatibility, and shelf life, not algorithmic performance.
No
The device is described as an accessory to dental implants, intended to protect the implant, maintain soft tissue during healing, and stabilize bone grafts. Its function is supportive during a healing process, rather than directly therapeutic in the sense of actively treating a disease or condition.
No
The device description indicates that healing abutments, healing caps, and closure screws are used to protect implant features and manage soft tissue during healing or stabilize bone grafts, not to diagnose a condition.
No
The device description clearly describes physical components (healing abutments, healing caps, closure screws, fixation caps) made of materials intended for implantation and interaction with soft tissue and bone. The performance studies also focus on sterilization, biocompatibility, and shelf life, which are relevant to physical medical devices, not software.
Based on the provided text, 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 Description: The description clearly states that these devices (healing abutments, healing caps, closure screws, and fixation caps) are intended for use with dental implants to protect the implant, maintain soft tissue, and stabilize bone grafts during the healing process.
- Lack of Diagnostic Function: There is no mention of these devices being used to analyze biological samples or provide diagnostic information about a patient's health condition. Their function is entirely related to the physical process of dental implant healing and bone augmentation.
Therefore, these devices fall under the category of dental devices used in surgical procedures, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Healing abutments, healing caps and closure screws are intended for use with the implants of the Straumann Dental Implant System to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Fixation caps are used to stabilize bone grafts in cases where bone augmentation is being performed in conjunction with implant placement.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Straumann Healing Abutments, Healing Caps, and Closure Screws are intended for use with the implants of the Straumann Dental Implant System (SDIS) to protect the inner features of the implant and to maintain, stabilize and form the soft tissue during the healing process. The devices are available in various diameters and heights. They are also not intended for use in immediate loading protocols; none of the devices of the Straumann Sterile Healing Solution are indicated for use in immediate loading protocols as they are intended to protect the internal features of the implant during the healing phase. When the implant has sufficient primary stability, the closure caps and fixation caps are used as a means to retain a bone graft used to augment the bone in the vicinity of the implant. These devices are not intended to be used with granular bone substitute materials or dental membranes.
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)
Test data to support the evaluation of the subject closure cap and fixation cap devices has been included directly or by reference as follows: Sterilization validation in accordance with ISO 11137 series of standards. Biocompatibility assessment per the ISO 10993 series of standards. Shelf Life validation in accordance ASTM F1980. No animal or human clinical studies were conducted.
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.
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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Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is simple and clean, and it is easily recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 7, 2016
Institut Straumann AG % Jennifer Jackson Director Of Regulatory Affairs And Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K161677
Trade/Device Name: Straumann Sterile Healing Solution Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: September 5, 2016 Received: September 9, 2016
Dear Jennifer 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.
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 and Part 809); 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
1
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 and Part 809), 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" (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.
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.
Michael J. Ryan -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
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Indications for Use
510(k) Number (if known) K161677
Device Name
Straumann® Sterile Healing Solution
Indications for Use (Describe)
Healing abutments, healing caps and closure screws are intended for use with the implants of the Straumann Dental Implant System to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Fixation caps are used to stabilize bone grafts in cases where bone augmentation is being performed in conjunction with implant placement.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
|X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| 5. | 510(k) Summary | K161677 |
|---|---|---|
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG) | |
| 60 Minuteman Road | ||
| Andover, MA 01810 | ||
| Contact Person: | Jennifer M. Jackson, MS | |
| Director of Regulatory Affairs and Quality | ||
| +1 (978) 747-2509 | ||
| Prepared By: | Christopher Klaczyk | |
| Head of North American Regulatory Affairs | ||
| Institut Straumann AG | ||
| +41 61 965 1260 | ||
| Date Prepared: | October 7, 2016 | |
| Product Code(s): | NHA (21 CFR 872.3630) | |
| Device Class: | II (21 CFR 872.3630) | |
| Classification Panel: | Dental | |
| Classification Name: | Endosseous dental implant abutment (21 CFR 872.3630) | |
| Proprietary Name: | Straumann® Sterile Healing Solution | |
| Predicate Device:: | K130808, Straumann® Sterile Healing Solution (Institut | |
| Straumann) | ||
| Reference Device(s): | K062129, Bone Level Implants (Institut Straumann) | |
| K120951, SMARTbuilder System (Osstem Implant Co.) | ||
| Device Description: | The Straumann Healing Abutments, Healing Caps, and Closure | |
| Screws are intended for use with the implants of the Straumann | ||
| Dental Implant System (SDIS) to protect the inner features of | ||
| the implant and to maintain, stabilize and form the soft tissue | ||
| during the healing process. The devices are available in various | ||
| diameters and heights. They are also not intended for use in | ||
| immediate loading protocols; none of the devices of the | ||
| Straumann Sterile Healing Solution are indicated for use in | ||
| immediate loading protocols as they are intended to protect the | ||
| internal features of the implant during the healing phase. | ||
| When the implant has sufficient primary stability, the closure | ||
| caps and fixation caps are used as a means to retain a bone graft |
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used to augment the bone in the vicinity of the implant. These devices are not intended to be used with granular bone substitute materials or dental membranes.
The subject devices are identified in the table below.
| Article
| Number | Description |
|---|---|
| 024.0000S | RC Healing Abutment, conical, Ø 4.5, H2 |
| 024.0001S | RC Healing Abutment, conical, Ø 4.5, H4 |
| 024.0002S | RC Healing Abutment, conical, Ø 4.5, H6 |
| 024.0003S | RC Healing Abutment, conical, Ø 6.0, H2 |
| 024.0004S | RC Healing Abutment, conical, Ø 6.0, H4 |
| 024.0005S | RC Healing Abutment, conical, Ø 6.0, H6 |
| 024.2100S | NC Closure Screw, H 0 |
| 024.2100S-04 | NC Closure Screw, H 0 (4-Pack) |
| 024.2105S | NC Closure Screw, H 0.5 |
| 024.2105S-04 | NC Closure Screw, H 0.5 (4-Pack) |
| 024.2220S | NC Closure & Fixation Cap, Ø 5.5mm, Ti |
| 024.4100S | RC Closure Screw, H 0 |
| 024.4100S-04 | RC Closure Screw, H 0 (4-Pack) |
| 024.4105S | RC Closure Screw, H 0.5 |
| 024.4105S-04 | RC Closure Screw, H 0.5 (4-Pack) |
| 024.4220S | RC Closure & Fixation Cap, Ø 5.5mm, Ti |
| 048.324S | NNC Closure Screw, H 0 |
| 048.324SV4 | NNC Closure Screw, H 0 (4-Pack) |
| 048.325S | NNC Closure Screw, H 0.5 |
| 048.325SV4 | NNC Closure Screw, H 0.5 (4-Pack) |
| 048.371SV4 | RN Closure Cap, H 0, Ti (4-Pack) |
| 048.373SV4 | RN Closure Cap, H 1.5 mm, Ti (4-Pack) |
Indications For Use: Healing abutments, healing caps and closure screws are intended for use with the implants of the Straumann Dental Implant System to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Fixation caps are used to stabilize bone grafts in cases where bone augmentation is being performed in conjunction with implant placement. Materials: The material for all Healing Abutments, Closure Caps and Closure Screws is commercially pure Titanium (grade 4)
conforming to ISO 5832-2.
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Technological Characteristics:
A comparison of the relevant technological characteristics between the subject and primary predicate devices is provided in the table that follows.
| Feature | Primary Predicate Device
Straumann Sterile Healing Solution | Subject Devices
Straumann Sterile Healing Solution |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use
K130808 | Closure screws, healing caps, and healing
abutments, are intended for use with the
straumann dental implant system (sdis) to
protect the inner configuration of the
implant and maintain, stabilize and form
the soft tissue during the healing process.
Customizable healing abutments made of
peek are for use for up to six months. | Healing abutments, healing caps and
closure screws are intended for use with the
implants of the Straumann Dental Implant
System to protect the inner configuration of
the implant and maintain, stabilize and
form the soft tissue during the healing
process. Fixation caps are used to stabilize
bone grafts in cases where bone
augmentation is being performed in
conjunction with implant placement. |
| Indications For Use
K120951 | SMARTbuilder System is a metal (Non-
resorbable membrane) device intended for
use with a dental implant to stabilize and
support of bone graft in dento-alveolar
bony defect sites. | The Indications for Use differ with the
removal of the PEEK abutments. The
subject devices do not include PEEK
abutments and only include Titanium
abutments; therefore the modification of
the Indications for Use is acceptable as the
PEEK abutment limitation for 6 months
does not apply to the subject device |
| Compatible Implants | Straumann Bone Level implants having the
NC and RC implant-to-abutment interface
geometries.
Straumann Tissue Level implants having
the NNC, RN and WN implant-to-abutment
interface geometries. | Straumann Bone Level implants having the
NC and RC implant-to-abutment interface
geometries.
Straumann Tissue Level implants having
the NNC and RN implant-to-abutment
interface geometries. |
| Material | Commercially pure grade 4 Titanium
per ISO 5832-2 | Commercially pure grade 4 Titanium
per ISO 5832-2 |
| Construction | One-piece solid device. | One-piece solid devices and two-piece
device assemblies. Two-piece devices are
supported via comparison with components
of the Osstem SMARTbuilder System
(K120951) |
| Packaging | Primary barrier package consists of a
PETG blister tray with a PETG insert and a
Tyvek 1073B lid stock. The primary
package is contained within a paperboard
shelf box. | Primary barrier package consists of a
PETG blister tray with a PETG insert and a
Tyvek 1073B lid stock. The primary
package is contained within a paperboard
shelf box. |
| Sterility | Provided sterile via gamma irradiation to a
Sterility Assurance Level of 10-6.
Cycle validated per ISO 11137-2. | Provided sterile via gamma irradiation to a
Sterility Assurance Level of 10-6.
Cycle validated per ISO 11137-2. |
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| Performance Data: | Test data to support the evaluation of the subject closure cap
and fixation cap devices has been included directly or by
reference as follows:
Sterilization validation in accordance with ISO 11137 series of standards. Biocompatibility assessment per the ISO 10993 series of standards. Shelf Life validation in accordance ASTM F1980 |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | No animal or human clinical studies were conducted. |
| Conclusions: | Based upon our assessment of the design and applicable
performance data, the subject devices have been determined to
be substantially equivalent to the identified predicate devices. |