(10 days)
RN SynOcta Temporary Meso Abutments are for use in RN Straumann Dental Implants for temporary restoration of single crowns in the anterior and posterior region for use up to six months.
Description of these Abutment is a temporary abutment made of medical grade plastic structure for immediate temporization by the clinician. This can be customized by the clinician and serves as a base for direct veneering or cemented restoration. The abutment is strengthened by an inlay of Titanium alloy that fits precisely into the Straumann Regular Neck (RN) implants.
The provided text is a 510(k) summary for the "RN synOcta Temporary Meso Abutment." This document is a premarket notification to the FDA for a medical device and therefore describes the device, its intended use, and claims substantial equivalence to previously cleared devices. It does not contain an acceptance criteria table, detailed study results, or information about the performance evaluation of a device against specific acceptance criteria in the way a research paper or a clinical trial report would.
Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not:
The document explicitly states that the device is "substantially equivalent" to a predicate device, which is the primary method of approval for 510(k) submissions. This means a new study to prove specific acceptance criteria is often not required if substantial equivalence can be demonstrated.
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as a table of numerical performance criteria. The acceptance criterion for a 510(k) device is primarily "substantial equivalence" to a predicate device. This implies that the new device must perform as safely and effectively as the predicate device.
- Reported Device Performance: The document states: "The Abutment is a temporary abutment... for immediate temporization by the clinician. This plastic structure can be customized by the clinician and serves as a base for direct veneering or cemented restoration. The abutment is strengthened by an inlay of Titanium alloy that fits precisely into the Straumann Regular Neck (RN) implants. It is substantially equivalent in design and intended use with the previously cleared synOcta Post for temporary restoration, K990342." This describes the device's function and composition, but not specific performance metrics or comparative data against a set of numerical acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided in the 510(k) summary. For a substantial equivalence claim, detailed testing data (like sample sizes for a clinical trial) might not be necessary if the design and material are sufficiently similar to the predicate and non-clinical bench testing or engineering analysis is deemed sufficient by the FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not provided. This type of detail is typical for studies involving human interpretation or subjective assessment, which is not the primary focus of this 510(k) summary for a physical medical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided. Adjudication methods are relevant for studies where multiple experts interpret data, which is not described in this document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This information is not provided. MRMC studies are typically for diagnostic imaging devices or AI-assisted diagnostic tools. This device is a dental implant abutment, a physical component used in dental restoration, not an imaging or AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not provided. This question is relevant to AI or automated diagnostic systems, not a physical dental abutment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- This information is not provided. For a physical medical device submitted via 510(k), the "ground truth" to establish safety and effectiveness is often based on engineering principles, materials science, biocompatibility testing, mechanical testing, and comparison to the predicate device's established safety and efficacy. Direct clinical "ground truth" in the sense of pathology or outcomes data from a de novo study is not typically required if substantial equivalence can be demonstrated through other means.
8. The sample size for the training set
- This information is not applicable/not provided. There is no mention of a "training set" because this device is not an AI or machine learning model.
9. How the ground truth for the training set was established
- This information is not applicable/not provided. As above, there is no "training set."
Summary of available information from the document:
The provided document is a 510(k) summary for a physical medical device (dental abutment). The primary "study" that proves the device meets acceptance criteria is the demonstration of substantial equivalence to an existing, legally marketed predicate device (synOcta Post for temporary restoration, K990342). This typically involves:
- Comparison of intended use: Both the new device and the predicate device are indicated for temporary restorations in the anterior and posterior region for up to 6 months.
- Comparison of design and materials: The new device is described as "very similar" in design to the predicate and made of "medical grade plastic structure" strengthened by a "Titanium alloy inlay."
- Engineering and performance testing (implied): While not detailed in this summary, a 510(k) submission for such a device would include non-clinical testing (e.g., mechanical, biocompatibility) to demonstrate that the new device performs as safely and effectively as the predicate, especially given similar materials and design.
The document does not describe a clinical trial, a study with human subjects, or an AI/software performance evaluation. Therefore, most of the questions relating to specific study methodologies, expert opinions, or AI performance metrics are not addressed in this 510(k) summary.
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Image /page/0/Picture/1 description: The image shows the text 'K051717' in a handwritten style. The characters are bold and slightly uneven, giving them a casual appearance. The text is likely a code or identifier, possibly for a document or item.
ATTACHMENT 6
510(k) Summary
Applicant's Name and Address 1.
Straumann Manufacturing (on behalf of Institut Straumann AG) 60 Minuteman Road Andover, MA 01810
| Telephone Number: | 978-747-2500 |
|---|---|
| Fax Number: | 978-747-0031 |
| Contact Person: | Linda JalbertVice President, Regulatory & Clinical Affairs |
Name of the Device 2.
| Trade Name: | RN synOcta Temporary Meso Abutment |
|---|---|
| Common Name: | Endosseous Dental Implant Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
Legally Marketed Devices to which Equivalence is Claimed (Predicate 3. Devices)
synOcta Post for Temporary Restoration, K990342 RN synOcta UCLA gold Abutment, K041295 ITI Protection Healing Caps, K962023
Description of the Device 4.
Desemption of these Abutment is a temporary abutment made of medical rtry Syrioota Tomporary moows for immediate temporization by the clinician. This grado plastic structure can be customized by the clinician and serves as a base for direct veneering or cemented restoration. The abutment is strengthened by an inlay of Titanium alloy that fits precisely into the Straumann Regular Neck (RN) implants. It is substantially equivalent in design and intended use with the previously cleared synOcta Post for temporary restoration, K990342.
Intended Use of the Device ട.
Like the predicate device, synOcta Post for temporary restoration, the RN synOcta Temporary Meso Abutment is indicated for temporary restorations in the anterior and posterior region for up to 6 months.
Basis for Substantial Equivalence ର.
The Straumann synOcta Temporary Meso Abutment is substantially equivalent to the oreviously cleared synOcta Post for temporary restoration, K990342. The intended use is identical to that of the predicate synOcta Post for temporary restoration. The design is also very similar to this device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 7 - 2005
Institut Straumann SA C/O Ms. Linda Jalbert President of Regulatory & Clinical Affairs Straumann USA 60 Minuteman Road Andover, Massachusetts 01810
Re: K051717
K051717
Trade/Device Name: RN synOcta Temporary Meso Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 23, 2005 Received: June 27, 2005
Dear Ms. Jalbert:
We have reviewed your Section 510(k) premarket notification of intent to market the device the We have reviewed your Scellon 310(t) producitially equivalent (for the referenced above and have decimined the are its smarketed predicate devices marketed in
indications for use stated in the enclosure) to legally marketed predice indications for use stated in the cholosaro, to regalized date of the Medical Device interstate commerce prior to May 20, 1770, cases and recordance with the provisions of Amendments, or to devices that have been rockselves approval of a premaints.
the Federal Food, Drug, and Cosmetic Act (Act that device, swhices to the general the Federal Food, Drug, and Cosment Act (rice) and et the device, subject to the general
approval application (PMA). You may, therefore, market the det include approval application (FMA). Tou may, and controls provisions of the Act include controls provisions of the Act. The gentina. connects good manufacturing practice, requirements for animons against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (sec above) into controls. Existing major regulations affecting (PMA), it may be subject to such additional controllar softitle 21, Parts 800 to 898. In
your device can be found in the Code of Federal Regulations, Title Tederal your device can be found in the Code of Peacharding your device in the Eederal Register.
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Page 2 - Ms. Jalbert
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 mount that I Driver and regulations and regulations administered by other Federal agencies. or the For ally 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 alle listing (21 et read 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) This letter will anow yourse bog finding of substantial equivalence of your device to a promarket notification - 11 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), n you donts 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 may obtain 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,
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
510(k) Number (if known): Kの5ι7L7
RN synOcta Temporary Meso Abutment Device Name:
Indications for Use:
RN SynOcta Temporary Meso Abutments are for use in RN Straumann Dental Implants RN 3yrOcca Tremporary restoration of single crowns in the anterior and posterior region for use up to six months.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kei Muluy for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K051717
Page 1 of 1
§ 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.)