(269 days)
No
The 510(k) summary describes a physical dental device (abutment and coping) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on biocompatibility, sterilization, and bench testing, not algorithmic performance.
No
The device provides a "support structure for a temporary aesthetic oral rehabilitation" and helps to "maintain, stabilize and shape the soft tissue during the healing phase". It is not directly treating a disease or condition, but rather assisting in the process of aesthetic and tissue management during recovery from dental implant surgery.
No
The device, a Straumann Immediate Temporary Abutment and Plastic Coping, is used to provide a support structure for temporary dental prosthetics and to manage soft tissue during healing. Its function is to provide physical support and scaffold for repair, rather than to diagnose medical conditions or identify diseases.
No
The device description explicitly states it consists of a titanium abutment and PMMA coping, which are physical hardware components.
Based on the provided information, 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 Straumann Immediate Temporary Abutment and Plastic Coping are physical components placed into the body (specifically, dental implants) to provide structural support for temporary dental restorations. They do not perform any tests on biological samples.
- Intended Use: The intended use is to support temporary crowns and shape soft tissue, which is a mechanical and structural function, not a diagnostic one.
- Device Description: The description details the materials and physical form of the components, consistent with a medical device for implantation/placement, not an IVD.
- Performance Studies: The performance studies focus on biocompatibility, sterilization, and MRI compatibility, which are relevant for implantable or placed medical devices, not typical for IVDs (which would focus on analytical and clinical performance related to testing).
Therefore, this device falls under the category of a medical device, but not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Straumann Immediate Temporary Abutment and associated Plastic Coping are indicated to be placed into Straumann dental implants (BL, BLT or BLX) to provide a support structure for a temporary aesthetic oral rehabilitation of partially edentulous patients with crowns. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase for up to 180 days.
The Straumann Immediate Temporary Abutment and associated Plastic Coping must be placed out of occlusion.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Straumann Immediate Temporary Abutment and associated Plastic Copinq consist of a titanium abutment and PMMA coping for the Straumann dental implants BL, BLT and BLX. The abutments are available in a variety of gingival heights and diameters to fit individual patient situations. The PMMA coping is compatible with the subject Immediate Temporary Abutments. The Straumann Immediate Temporary Abutment and associated Plastic Coping are indicated to provide a support structure for a temporary aesthetic oral rehabilitation of partially edentulous patients with crowns. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase for up to 180 days.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral
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)
Biocompatibility Testing: The subject devices have been assessed for biological safety according to ISO 10993-1:2009 and FDA Guidance document "Use of International Standard ISO 10993-1". Biocompatibility testing was not performed for the abutments as they are equivalent to primary and reference predicate devices. For PMMA plastic copings, Cytotoxicity testing according to ISO 10993-5:2009 and Chemical Analysis according to ISO 10993-18:2020 were performed, along with a toxicology evaluation.
Sterilization: The Immediate Temporary Abutments are delivered sterile via Gamma Irradiation. The PMMA plastic coping is delivered non-sterile and is to be manually cleaned and disinfected according to the Instructions for Use. A sterilization validation assessment was performed according to ISO 11137 for the Immediate Temporary Abutments, concluding they can be adopted into the same sterilization process validated for K192401. A high-level disinfectant validation was performed on a worst-case PMMA device, concluding that the subject PMMA Plastic Coping is not a new worst case and the cleaning method is effective. The packaging and shelf life (5 years) are identical to the reference device K192401.
Bench Testing: The subject devices are MRI Conditional and do not introduce new material or worst-case scenarios, represented under reference device K190662.
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.
K192401, K181703, K190662, K041070
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 18, 2021
Institut Straumann AG % Chanrasmey White Regulatory Affairs Specialist Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801
Re: K201681
Trade/Device Name: Straumann Immediate Temporary Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: February 12, 2021 Received: February 16, 2021
Dear Chanrasmey White:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201681
Device Name Straumann® Immediate Temporary Abutments
Indications for Use (Describe)
The Straumann Immediate Temporary Abutment and associated Plastic Coping are indicated to be placed into Straumann dental implants (BL, BLT or BLX) to provide a support structure for a temporary aesthetic oral rehabilitation of partially edentulous patients with crowns. Temporary components can be used prior to the final components to maintain, stabilize and shape the soft tissue during the healing phase for up to 180 days.
The Straumann Immediate Temporary Abutment and associated Plastic Coping must be placed out of occlusion.
| 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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3
Straumann® Immediate Temporary Abutments
510(k) Summary
K201681 510(k) Summary 5
Submitter 5.1
60 Minuteman Road
Andover, MA 01810
978-747-0023 Fax Number:
- Contact Person: Chanrasmey White
March 17, 2021 Date of Prepared:
5.2 Device
| Trade Name: | Straumann® Immediate Temporary 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:
-
K122192 Straumann Temporary Abutments, PMMA
Reference Predicate: -
K192401 Straumann Screw Retained Abutments
-
K181703 BLX Implant System
-
K190662 MRI Compatibility for Existing Straumann Dental Implant System
-
K041070 Straumann Temporary Coping
4
Straumann® Immediate Temporary Abutments
510(k) Summary
Device Description 5.4
The Straumann Immediate Temporary Abutment and associated Plastic Copinq consist of a titanium abutment and PMMA coping for the Straumann dental implants BL, BLT and BLX. The abutments are available in a variety of gingival heights and diameters to fit individual patient situations. The PMMA coping is compatible with the subject Immediate Temporary Abutments. The Straumann Immediate Temporary Abutment and associated Plastic Coping are indicated to provide a support structure for a temporary aesthetic oral rehabilitation of partially edentulous patients with crowns. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase for up to 180 days.
5.5 Indications for Use
The Straumann Immediate Temporary Abutment and associated Plastic Coping are indicated to be placed into Straumann dental implants (BL, BLT or BLX) to provide a support structure for a temporary aesthetic oral rehabilitation of partially edentulous patients with crowns. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase for up to 180 days.
The Straumann Immediate Temporary Abutment and associated Plastic Coping must be placed out of occlusion.
5.6 Technological Characteristics
The subject device is equivalent to the primary predicate and reference devices sharing the same material and fundamental operating principles. The differences in indications for use are addressed in performance testing provided in this submission demonstrating equivalent product performance. The subject and the primary predicate devices are intended to support temporary prosthetic reconstructions. The subject devices have a contact duration of up to 180 days compared to the primary predicate and reference devices, biocompatibility testing has been performed to support the 180 duration of use. The technological characteristics of the subject device are compared to the primary predicate and reference devices in Table 2. The subject devices are one-piece abutments opposed to the two-piece temporary abutments cleared per K122192. The one-piece design allows the abutment to be directly screwed into the
5
Straumann® Immediate Temporary Abutments
510(k) Summary
implant. The differences in technological differences are addressed in the performance testing provided in the submission which demonstrates equivalency in product performance.
6
Straumann® Immediate Temporary Abutments
510(k) Summary
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE |
|---|---|---|---|---|
| K Number | Subject Device | K122192 | K192401 | K181703 |
| Indications for Use | The Straumann Immediate | |||
| Temporary Abutment and | ||||
| associated Plastic Coping are | ||||
| indicated to be | ||||
| placed into Straumann dental | ||||
| implants (BL, BLT or BLX) to | ||||
| provide a support structure for a | ||||
| temporary | ||||
| aesthetic oral rehabilitation of | ||||
| partially edentulous patients with | ||||
| crowns. Temporary components | ||||
| can be used prior to the insertion | ||||
| of the final components to | ||||
| maintain, stabilize and shape the | ||||
| soft tissue during the healing | ||||
| phase for up to 180 days. | ||||
| The Straumann Immediate | ||||
| Temporary Abutment and | ||||
| associated Plastic Coping must be | ||||
| placed out of occlusion. | Straumann Temporary Abutments | |||
| VITA CAD-Temp are indicated for | ||||
| use with Straumann Bone Level | ||||
| and Tissue Level implants for | ||||
| temporary crown and bridge | ||||
| restorations, and to maintain, | ||||
| stabilize and shape the soft tissue | ||||
| during the healing phase for up to | ||||
| six months, and should be placed | ||||
| out of occlusion. | Prosthetic components directly or | |||
| indirectly connected to the | ||||
| endosseous dental implant are | ||||
| intended for use as an aid in | ||||
| prosthetic rehabilitations. | ||||
| Temporary components can be | ||||
| used prior to the insertion of the | ||||
| final components to maintain, | ||||
| stabilize and shape the soft tissue | ||||
| during the healing phase; they may | ||||
| not be placed into occlusion. Final | ||||
| abutments may be placed into | ||||
| occlusion when the implant is fully | ||||
| osseointegrated. | ||||
| Temporary Abutments have a | ||||
| maximum duration of usage of 180 | ||||
| days. | Straumann® BLX Implants | |||
| Straumann® BLX Implants are | ||||
| suitable for endosteal implantation | ||||
| in the upper and lower jaw and for | ||||
| the functional and esthetic oral | ||||
| rehabilitation of edentulous and | ||||
| partially edentulous patients. BLX | ||||
| Implants can be placed with | ||||
| immediate function on single-tooth. | ||||
| bar and bridge applications when | ||||
| qood primary stability is achieved | ||||
| and with appropriate occlusal | ||||
| loading to restore chewing | ||||
| function. The prosthetic | ||||
| restorations are connected to the | ||||
| implants through the | ||||
| corresponding abutment | ||||
| components. | ||||
| Straumann® BLX SRAs and | ||||
| Anatomic Abutments | ||||
| Prosthetic components directly or | ||||
| indirectly connected to the | ||||
| endosseous dental implant are | ||||
| intended for use as an aid in | ||||
| prosthetic rehabilitations. | ||||
| Temporary components can be | ||||
| used prior to the insertion of the | ||||
| final components to maintain, | ||||
| stabilize and shape the soft tissue | ||||
| during the healing phase; they may | ||||
| not be placed into occlusion. Final | ||||
| abutments may be placed into | ||||
| occlusion when the implant is fully | ||||
| osseointegrated. BLX Temporary | ||||
| Abutments have a maximum | ||||
| duration of usage of 180 days. | ||||
| Material | Abutment: | |||
| Ti-6Al-7Nb | ||||
| Plastic Coping: | ||||
| Polymethyl Methacrylate (PMMA) | Ti-6Al-7Nb | |||
| Polymethyl Methacrylate (PMMA) | Ti-6Al-7Nb | Ti-6Al-7Nb | ||
| Implant Compatibility | BL, BLT, BLX | BL, BLT, TL | BL, BLT | BLX |
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE |
| K Number | Subject Device | K122192 | K192401 | K181703 |
| Abutment Diameter | Ø3.8 and 4.5 | Ø5.0, 7.0, and 10.0 mm | Ø3.5 and 4.6 mm | Ø4.6 mm |
| Gingival Heights | BL and BLT - 1, 2, and 3 mm | |||
| BLX - 1.5, 2.5, and 3.5 mm | 1.0, 2.5, 4.0, and 5.5 mm | 1.5, 2.5, 3.5, 4.5, and 5.5 mm | 1.5, 2.5, 3.5, and 4.5 mm | |
| Abutment Angulation | 0° | 0° | 0, 17 and 30° | 0, 17 and 30° |
| Indexing Type/ | ||||
| Presence | Non-Engaging | Engaging | Straight - Non-Engaging | Straight - Non-Engaging |
| Integrated Screw | ||||
| Technology | Yes | |||
| Machined one-piece | No | |||
| Coupled with a base screw | Yes - The straight abutments are | |||
| machined one-piece | Yes - The straight abutments are | |||
| machined one-piece | ||||
| Restoration Type | Cemented | Cemented | Screw-retained | Screw-retained |
| Duration of Use | 180 days | 180 days | unlimited | unlimited |
| Sterilization | Sterile - Gamma Irradiation | Non-Sterile | ||
| End User - Steam Autoclave | Sterile - Gamma Irradiation | Sterile - Gamma Irradiation | ||
| Loading | Single Unit | Single and Multi Unit | Single and Multi Unit | Single and Multi Unit |
7
Straumann® Immediate Temporary Abutments
510(k) Summary
Table 1 – Immediate Temporary Abutment – Comparison Matrix
8
Straumann® Immediate Temporary Abutments
510(k) Summary
| FEATURE | PROPOSED DEVICE | REFERENCE DEVICE |
|---|---|---|
| K Number | Subject Device | K041070 |
| Indications for Use | The Straumann Immediate Temporary | |
| Abutment and associated Plastic Coping are | ||
| indicated to be placed into Straumann dental | ||
| implants (BL, BLT or BLX) to provide a support | ||
| structure for a temporary aesthetic oral | ||
| rehabilitation of partially edentulous patients | ||
| with crowns. Temporary components can be | ||
| used prior to the insertion of the final | ||
| components to maintain, stabilize and shape | ||
| the soft tissue during the healing phase for up | ||
| to 180 days. | ||
| The Straumann Immediate Temporary | ||
| Abutment and associated Plastic Coping must | ||
| be placed out of occlusion. | Temporary Copings are intended to serve as a | |
| base for temporary restorations. | ||
| Material | Polymethyl methacrylate (PMMA) | Polymethyl methacrylate (PMMA) |
| Restoration Type | Cemented | Cemented |
| Duration of Use | 180 days | 30 days |
| Sterilization | Non-Sterile | |
| Cleaned and disinfected | Non-Sterile |
Table 2 – Plastic Coping – Comparison Matrix
9
Straumann® Immediate Temporary Abutments
510(k) Summary
Performance Data 5.7 -
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The subject devices have been assessed for biological safety according to ISO 10993-1:2009 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and to the FDA Guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on June 16, 2016" for the subject device. The subject abutments are equivalent with regard to nature of body contact, duration of use, material formulation and sterilization methods compared to the primary and reference predicate devices and therefore, no new testing have been performed as biocompatibility is represented in the primary and reference predicate devices.
In support of the subject PMMA plastic copings, Cytotoxicity testing according to ISO 10993-5:2009, "Biological evaluation of medical devices – Part 5: Test for in vitro cytotoxicity" and Chemical Analysis according to ISO 10993-18: 2020 "Chemical characterization of medical device materials within a risk management process" has been performed. In addition to the above testing a toxicology evaluation has been performed in support of the subject PMMA plastic copings. The test and evaluation performed the biocompatibility of the subject PMMA plastic copings.
Sterilization
The subject device are single patient devices. The Immediate Temporary Abutments will be delivered in a sterile packaging via Gamma Irradiation and the PMMA plastic coping will be delivered non-sterile. The PMMA plastic coping is to be manually cleaned and disinfected according to the Instructions for Use.
A sterilization validation assessment was performed according to ISO 11137 for the Immediate Temporary Abutments. The assessment concluded the proposed Immediate Temporary
10
Straumann® Immediate Temporary Abutments
510(k) Summary
Abutment can be adopted into the same sterilization process validated for the Straumann Sterile Prosthetics cleared for reference predicate K192401.
A high-level disinfectant validation was performed on the worst case PMMA device. The worst case was selected based on the most challenging designs for high level disinfection process due to size, surface, complexity and accessibility of the liquid solution. The subject PMMA Plastic Coping is not considered a new worst case and therefore can adopt the validation demonstrating the high-level disinfectant cleaning method can effectively disinfect the Plastic Coping.
The packaging of the Straumann® Immediate Temporary Abutments is identical to the packaging of the reference device K192401. There are no changes to the sterilization method or production process compared to the reference device. The shelf life for the proposed devices is 5 years identical to the reference device.
Bench Testing
The subject devices are MRI Conditional and do not introduce a new material or worst-case scenario and is represented under reference device K190662.
Conclusion 5.8
The documentation submitted in this premarket notification demonstrates the subject devices are substantially equivalent to the primary predicate and reference devices.