RN SYNOCTA TEMPORARY MESO ABUTMENT

K051717 · Institut Straumann SA · NHA · Jul 7, 2005 · Dental

Device Facts

• Record ID: K051717
• Device Name: RN SYNOCTA TEMPORARY MESO ABUTMENT
• Applicant: Institut Straumann SA
• Product Code: NHA · Dental
• Decision Date: Jul 7, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

RN synOcta Temporary Meso Abutment is a temporary dental abutment used for immediate temporization. Device consists of a medical-grade plastic structure reinforced with a titanium alloy inlay that fits into Straumann Regular Neck (RN) implants. Clinicians customize the plastic structure to serve as a base for direct veneering or cemented restorations. Used in dental clinics by clinicians to provide temporary single crown restorations for up to 6 months. Output is a customized abutment base that facilitates temporary tooth replacement, aiding in patient aesthetics and function during the healing period prior to permanent restoration.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Medical-grade plastic structure with titanium alloy inlay. Designed for compatibility with Straumann Regular Neck (RN) implants. Mechanical fixation via titanium inlay. Non-sterile (implied by temporary nature and clinical customization).

Indications for Use

Indicated for temporary restoration of single crowns in the anterior and posterior region for up to 6 months in patients requiring Straumann RN dental implants.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

• synOcta Post for Temporary Restoration (K990342)
• RN synOcta UCLA gold Abutment (K041295)
• ITI Protection Healing Caps (K962023)

Submission Summary (Full Text)

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### 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<br>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.

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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 [phone]. 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 [phone] or [phone] 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

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