STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BAR

K101465 · Institut Straumann AG · NHA · Dec 13, 2010 · Dental

Device Facts

• Record ID: K101465
• Device Name: STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BAR
• Applicant: Institut Straumann AG
• Product Code: NHA · Dental
• Decision Date: Dec 13, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Straumann® CARES® Screw-Retained Bridge and Straumann® CARES® Dolder® Bar indicated for use as bars and bridges that attach to dental implants (Straumann RN (Regular Neck) Ø 4.8 mm and WN (Wide Neck) Ø 6.5 mm) in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The Straumann CARES Screw-Retained Bridge can be designed for specific patient sizes and spans that are attached to 2 to 16 implants. The Straumann CARES Dolder Bar can be designed for specific patient sizes and spans that are attached to 2 to 10 implants.

Device Story

Straumann CARES Screw-Retained Bridges and Dolder Bars are patient-specific dental restorative frameworks. Input data consists of 3D scans of dental master models containing implant analogs and scanbodies. Dental technicians use CAD software to design the framework based on dentist prescriptions. Digital datasets are transmitted via internet to Straumann CADCAM for milling from cobalt-chromium alloy blanks. Devices are finished by dental laboratories using standard techniques (e.g., veneering porcelain for bridges, overdenture attachments for bars). Used in dental clinics/laboratories; operated by dental technicians and dentists. Final restorations attach directly to Straumann dental implants via screws to restore chewing function in edentulous patients.

Clinical Evidence

Bench testing only. Testing included mechanical property verification (density, proof strength, Vickers hardness, CTE), ceramic bonding strength (debonding/crack-initiation > 25 MPa), biocompatibility (cytotoxicity), static corrosion testing, and dynamic fatigue testing (connection and connector testing). All tests met predefined acceptance criteria.

Technological Characteristics

Cobalt-chromium base metal alloy (ISO 22674, ISO 9693). CAD/CAM milled. Interfaces with Straumann RN (4.8mm) and WN (6.5mm) implants. Screw-retained. Software-driven design via 3D scanning and CAD.

Indications for Use

Indicated for partially or totally edentulous patients requiring dental implant-supported bars or bridges to restore chewing function. Compatible with Straumann RN (4.8mm) and WN (6.5mm) implants. Bridges support 2-16 implants; bars support 2-10 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

• Procera Implant Bridge Overdenture (K041236, K090069)
• ETKON ES1, MODEL 019.0001, ETKON VISUAL (K093113)

Submission Summary (Full Text)

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K101465

# DEC 1 3 2010

# 510(k) SUMMARY

| Submitter | |
|------------------------------------|------------------------------------------------------------------------------------------|
| Company: | Institut Straumann AG |
| Street: | Peter Merian-Weg 12 |
| ZIP-Code, City: | CH-4002 Basel |
| Federal State: | Basel-City |
| Country: | Switzerland |
| Establishment Registration Number: | 9613348 |
| Official Correspondent: | Dr. Toni K. Joergensen,<br>Head of Corporate Regulatory Affairs<br>Institut Straumann AG |
| Phone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Submitter: | Dr. Andreas Petermann,<br>Head of Regulatory Affairs<br>Straumann CADCAM GmbH |
| Phone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Date: | November 23, 2010 |
| Name of Device | |
| Proprietary Name: | Straumann® CARES® Screw-Retained Bridge<br>Straumann® CARES® Dolder® Bar |
| Classification Name | Endosseous Dental Implant Abutment |
| Common Name: | Implant Bridge |
| Regulation Number and Product Code | |
| Regulation Number: | 21 C.F.R § 872.3630 |
| Product Code: | 76 NHA |

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K101465

#### Predicate Devices

Procera Implant Bridge Overdenture ........................................................................................................................................... Procera Implant Bridge ....................................................................................................................................................... ETKON ES1, MODEL 019.0001, ETKON VISUAL, K093113 STRAUMANN CADCAM ABUTMENT

#### Device Description

Straumann® CARES® Screw-Retained Bridges and Straumann® CARES® Dolder® Bars are dental restorative devices intended to be attached directly to dental implants by basel screws. The Straumann CARES Screw-Retained Bridge and Straumann CARES Dolder Bar are designed with implant interfaces comparable to a single tooth abutment which are attached to a Straumann implant RN (Regular Neck) Ø 4.8 mm and WN (Wide Neck) Ø 6.5 mm.

Image /page/1/Picture/5 description: The image shows a round object with a complex structure on top. The object appears to be made of a rough, textured material. The structure on top consists of interconnected elements, possibly metallic, forming a network of lines and shapes. The lighting in the image is somewhat diffused, creating shadows and highlights that emphasize the texture of the object and the complexity of the structure.

Example screw retained bar to be mounted on 5 dental implants (may be fixed on 2 to 10 implants)

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K101465

Image /page/2/Picture/1 description: The image shows a dental impression. The impression is made of a pink material and is of the upper teeth. The impression is set in a tray and is ready to be used to create a model of the teeth.

Example screw retained bridge to be mounted on 5 dental implants (may be fixed on 2 to 16 implants)

The implant positions and oral situation are recognized by a scan of a dental master model with implant analogs and scanbodies. Based on the scan data, the dental technician selects the proper implant interfaces and designs the bar or bridge according to a dentist's prescription.

Once the Straumann CARES Screw-Retained Bridge or Straumann CARES Dolder Bar is designed, the digital dataset is sent to Straumann CADCAM by an internet connection where the bridge or bar is milled from a cobaltchromium-based blank.

Straumann CARES Screw-Retained Bridges and Straumann CARES Dolder Bars allow for individual customization regarding function and esthetics. They attach directly to Straumann dental implants. The device is intended to be finished into a bridge or overdenture using standard dental laboratory techniques and materials. The devices are CAD-derived, CAMproduced and have a scanner as its data source.

The milling blanks used for the manufacture of Straumann CARES Screw-Retained Bridge and Straumann CARES Dolder Bar are manufactured from a cobalt chromium base metal alloy, which has been tested and

39

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found biocompatible for its intended use. The cobalt chromium alloy meets the physical and mechanical requirements of ISO 22674, Dentistry - Metallic materials for fixed and removable restorations and appliances and ISO 9693, Metal-ceramic dental restorative systems.

#### Intended Use

The Straumann® CARES® Screw-Retained Bridge and Straumann® CARES® Dolder® Bar indicated for use as bars and bridges that attach to dental implants (Straumann RN (Regular Neck) Ø 4.8 mm and WN (Wide Neck) Ø 6.5 mm) in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

The Straumann CARES Screw-Retained Bridge can be designed for specific patient sizes and spans that are attached to 2 to 16 implants.

The Straumann CARES Dolder Bar can be designed for specific patient sizes and spans that are attached to 2 to 10 implants.

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K101465

# Technical Comparison to the Predicate Device

The Straumann CARES Screw-Retained Bridges and Straumann CARES Dolder Bars are equivalent in design and materials to the predicate device.

Table 1 compares the Straumann CARES Screw-Retained Bridges and Straumann CARES Dolder Bars to the predicate devices:

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# Table 1

| Characteristic | Straumann CARES®<br>Screw-Retained Bridge<br>Straumann CARES<br>Dolder® Bar | Procera Implant Bridge<br>K041236, K090069 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Indicated for use as a<br>screw retained bridge or<br>bar framework in the<br>treatment of partially or<br>totally edentulous jaws<br>for the purpose of<br>restoring chewing<br>function. | Same |
| Intended Use | Intended to be finished<br>into a bridge or<br>overdenture using<br>standard dental<br>laboratory techniques and<br>materials. | Same |
| Connection Type | Screw retained dental<br>restorations | Same |
| Connection Level | Dental implant | Same |
| Implant Interface Type | Straumann® RN (Regular<br>Neck) Ø 4.8 mm and WN<br>(Wide Neck) Ø 6.5 mm | Procera and Straumann<br>(RN (Regular Neck) Ø 4.8<br>mm and WN (Wide Neck)<br>Ø 6.5 mm) implant<br>interface type |
| Design Parameters | 3D scan and CAD | Same |
| Manufacturing Method | CADCAM milling from<br>milling blanks | Same |
| Material (bar and bridge) | chromium/cobalt dental<br>alloy | titanium (K041236)<br>titanium,<br>titanium/vanadium alloy,<br>or chromium/cobalt alloy<br>(K090069) |
| Finishing Method | Bridge: intended to be<br>finished into a bridge by<br>application of a veneering<br>porcelain layer.<br>Bar: intended to be<br>finished into overdenture<br>using standard dental<br>laboratory techniques and<br>materials. | Same |

Cobalt/chromium alloys are widely used in dentistry as non-precious dental alloy for cast and CADCAM fabrication of cementable crowns and

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bridges. Such alloys are regulated by 21CFR872.3710, product code EJH and are exempt from 510(k) requirements.

## Non-Clinical Testing

Table 2 summarizes the metallic material properties of the Straumann CARES Screw-Retained Bridge and Dolder Bar.

Table 2

| Property | Unit | Acceptance criteria<br>with and without<br>thermal treatment | Conclusion |
|------------------------------|-------------|--------------------------------------------------------------|------------|
| Color | na3 | Silver gray | passed |
| Density | g/cm³ | 8.3 | passed |
| Solubility in water | mg/l | insoluble | passed |
| Proof strength Rp0.2 | MPa | > 360 | passed |
| Vickers hardness | HV10 | 260 | na |
| Elongation after<br>fracture | % | > 2.0 | passed |
| CTE (25-500°C) | 10-6<br>K-1 | 14.4 | na |
| Solidus | °C | 1320 | na |
| Liquidus | °C | 1420 | na |

³ na is a notation for not applicable

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Table 3 summaries the ceramic bonding properties of the Straumann CARES Screw-Retained Bridge and Dolder Bar.

Table 3

| Veneering porcelain | Debonding/crack-<br>initiation strength $\tau_b$<br>[MPa] | Acceptance criterion | Conclusion |
|-------------------------------|-----------------------------------------------------------|----------------------|------------|
| Initial MC (GC) | > 25 MPa | | passed |
| IPS InLine (Ivoclar Vivadent) | > 25 MPa | | passed |
| HeraCeram (Heraeus Kulzer) | > 25 MPa | | passed |
| VM13 (Vita Zahnfabrik) | > 25 MPa | | passed |

Table 4 summaries the biocompatibility testing performed on the Straumann CARES Screw-Retained Bridge and Dolder Bar.

Table 4

| Test Method | Biocompatibility<br>Acceptance<br>criteria | Results |
|-----------------------------------|--------------------------------------------|---------|
| Cytotoxicity of extract | < 30 % | passed |
| Organic leachables<br>qualitative | na4 | na |
| Leachables quantitative | na | na |

4 na is a notation for not applicable

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Table 5 summaries the static corrosion testing performed on the Straumann CARES Screw-Retained Bridge and Dolder Bar.

#### Table 5

| Composite<br>Material | Units | Acceptance<br>Criterion | Results |
|-----------------------|--------|-------------------------|---------|
| Cobalt (Co) | µg/cm² | ≤ 100 | passed |
| Chromium (Cr) | µg/cm² | ≤ 100 | passed |
| Aluminum (Al) | µg/cm² | ≤ 100 | passed |
| Titanium (Ti) | µg/cm² | ≤ 100 | passed |
| Niobium (Nb) | µg/cm² | ≤ 100 | passed |
| Tungsten (W) | µg/cm² | ≤ 100 | passed |
| Silicon (Si) | µg/cm² | ≤ 100 | passed |
| Manganese (Mn) | µg/cm² | ≤ 100 | passed |
| Iron (Fe) | µg/cm² | ≤ 100 | passed |
| Beryllium (Be) | µg/cm² | ≤ 100 | passed |
| Cadmium (Cd) | µg/cm² | ≤ 100 | passed |

Table 6 summarizes the dynamic fatigue testing performed on the Straumann CARES Screw-Retained Bridge and Dolder Bar.

Table 6

| Composite Material | Results |
|-----------------------------------------------|---------|
| Minimal body testing<br>(Connection testing) | passed |
| Free hanging bridge<br>(Connector testing) | passed |
| Free end pontic bridge<br>(Connector testing) | passed |

Validation of the CARES Visual CAD software provides evidence that design parameters for the Straumann CARES Screw-Retained Bridges and Straumann CARES Dolder Bars have met their pre-determined acceptance criteria and that dental restorations meeting their design specifications can be manufactured by Straumann CAM milling devices

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# 14101465

## Conclusion

Non-clinical testing presented in this 510(k) demonstrate that the Straumann CARES Screw-Retained Bridge and Straumann CARES Dolder® Bar met predefined acceptance criteria and successfully passed verification and validation testing. The information presented in this 510(k) demonstrated that the Straumann CARES Screw-Retained Bridge and Straumann CARES Dolder® Bar are substantially equivalent to the predicate device.

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Image /page/10/Picture/1 description: The image shows a logo with two distinct parts. On the left is a circular seal with text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA". To the right of the seal is a stylized graphic that resembles three curved lines or waves stacked on top of each other. The graphic is black and stands out against the white background.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Institut Straumann AG C/O Ms. Janet Kay Regulatory and Clinical Affairs Director Straumann USA 60 Minuteman Road Andover, Massachusetts 01810

DEC 1 3 2010

Re: K101465

K101465
Trade/Device Name: Straumann® CARES® Screw-retained Bridge Straumann® CARES® Dolder Bar Regulation Number: 21 CFR. 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 6, 2010 Received: December 7, 2010

Dear Ms. Kay:

We have reviewed your Section 510(k) premarket notification of intent to market the device t We have reviewed your Section 310(x) presidentially equivalent (for the referenced above and have declinities mo to hegally marketed predicate devices marketed in
indications for use stated in the mC00sure) to tegans data of the Medical Device indications for use stated in the enclosers, we cenactment date of the Medical Device interstate comments, or to way 20, 1770, can reclassified in accordance with the provisions of Amendments, or to devices that have been roads and require approval of a premaint
the Federal Food, Drug, and Cosmetic Act (Act) that do subject to the general the Federal Food, Drug, and Cosmetic Act (rec) that evice, subject to the general
approval application (PMA). You may, therefore, market the device, subject to the general approval application (FMA). Tou may, moreontrols provisions of the Act include controls provisions of the Act. The genting of devices, good manufacturing practice, requirements for annual registration, institution good on . Please note: CDRH doss
labeling, and prohibitions against misbranding and adulteration. Please notes on thougher labeling, and pronibilions against insults and and in a remind you, however,
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
ns affective and the states to the Frinting major requlations affecting w If your device is classified (see above) mo only. Fassing major regulations affecting your
(PMA), it may be subject to additional controls. Title 21, Parts 800 to 898 , In (PMA), it may be subject to adultional controllations. Title 21, Parts 800 to 898. In
device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In device can be found in the Code of Federal Regulations, wour device in the Federal Register.

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#### Page 2- Mr. Kay

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s Issualice of a substantial offer requirements
mean that FDA has made a determination that your device Federal agencies mean that FDA has made a delemination maily of a winistered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by registration of the Act or any Federal statues and regulations and limited to: registration
You must comply with all the Act's requirements, including, but not regarting You must comply whil an the Act 3 requirements, and 801); medical device reporting and listing (21 CFR Part 807), laocing (21 CFR 803); good manufacturing
(reporting of medical device-related adverse events) (21 CFR 803); good manufacturing (reporting of medical device-telated adverse evenis) (2) eggulation (21 CFR Part 820);
practice requirements as set forth in the quality systems (QS) regulation (21 af 2 practice requirements as set form in the quality of seems ( ( + ) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm113809.html for http://www.rda.gov/About/DA/CentersOfHotel's (CDRH's) Office of Compliance. Also, the Center for Devices and Radiological results of teference to premarket notification" please note the regulation ennitied, "Whoolding of receing of adverse events under the MDR regulation (21 CFR Part 803), please go to

MDR regulation (21 CFN Far 609), prease go w
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.html for the CDRH's http://www.ida.gov/Medical/Dovetrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the You may oblain offer general information on Jour Assistance at its toll-free Division of Sman Manufacturers of 301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Bunney

Anthony D. Watson, B.S., M.S., M.B.A. 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): Қ | Օ\ Կ (65

Straumann® CARES® Screw-retained Bridge Device Name: Straumann® CARES® Dolder® Bar

Indications for Use:

The Straumann® CARES® Screw-retained Bridge and Straumann® CARES® Dolder® Bar are indicated for use as bars and bridges that attach to dental implants (Straumann RN (Reqular Neck) Ø4.8mm and WN (Wide Neck) Ø6.5mm) in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

The Straumann® CARES® Screw-retained Bridge is available in different sizes and spans and can be fitted on 2 to 16 implants.

The Straumann® CARES® Dolder® Bar is available in different sizes and spans and can be fitted on 2 to 10 implant.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of DCRH, Office of Device Exaluation (ODE)

Susan Runnt

(Division Sign-Off)
Division of Anesthesiology, General Hospitable 1 of 1
Division of Anesthesiology, General Devices Division of Anesthous Devices

Number: K10146

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