(10 days)
Not Found
No
The summary describes a physical dental abutment and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a temporary abutment used for dental restoration, not for treating or curing a disease or condition.
No.
The device is described as a temporary abutment for dental restoration, serving as a base for veneering or cemented restoration. Its purpose is to physically restore rather than diagnose a medical condition.
No
The device description clearly states it is a "temporary abutment made of medical grade plastic structure" with a "Titanium alloy" inlay, indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The RN SynOcta Temporary Meso Abutments are physical components used in dental procedures to support temporary restorations on dental implants. They are implanted into the patient's mouth and do not involve testing samples taken from the body.
- Intended Use: The intended use clearly states "for temporary restoration of single crowns in the anterior and posterior region," which is a direct clinical application, not a diagnostic test.
Therefore, this device falls under the category of a medical device used for treatment/restoration, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
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.
Product codes
NHA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior and posterior region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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 Jalbert |
| Vice 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.
1
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.
2
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
3
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
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