K Number

Device Name

STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUM

Manufacturer

STRAUMANN USA

Date Cleared

2011-11-16

(99 days)

Product Code

NHA

Regulation Number

872.3630

Intended Use

The Straumann® CARES® Screw-retained Bridge Titanium and Straumann® CARES® Dolder® Bar Titanium are indicated for use as bars and bridges that attach to dental implants (Straumann Regular Neck (RN) Ø4.8mm and Wide Neck (WN) Ø6.5mm) in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The Straumann® CARES® Screw-retained Bridge Titanium is available in different sizes and spans and can be fitted on 2 to 16 implants. The Straumann® CARES® Dolder® Bar Titanium is available in different sizes and spans and can be fitted on 2 to 10 implants.

Device Description

Straumann CARES Screw-retained Bridge, Titanium (Ti) and Straumann CARES Dolder Bar Titanium (Ti) are dental restorative devices intended to be attached directly to dental implants by basal screws. Straumann CARES Screw-retained Bridge Ti and Straumann CARES Dolder Bar Ti are designed with implant interfaces comparable to a single tooth abutment which are attached to a Straumann implant with prosthetic platforms Regular Neck (RN) Ø4.8mm and Wide Neck (WN) Ø6.5mm. 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 Ti and Straumann CARES Dolder Bar Ti is designed the digital dataset is sent to Straumann CADCAM by internet connection where the bridge or bar is milled from a Titanium-based blank. Straumann CARES Screw-retained Bridge Ti and Straumann CARES Dolder Bar Ti 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 CADderived, CAM-produced and have a scanner as its data source. The milling blanks used for the manufacture of Straumann CARES Screwretained Bridge Ti and Straumann CARES Dolder Bar Ti are manufactured from Titanium, grade 4, which is biocompatible for its intended use.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K101465

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a CAD/CAM process for designing and milling dental prosthetics based on scan data, which is a standard digital workflow and does not mention or imply the use of AI or ML for design or analysis.

Therapeutic

No.
The device is described as a dental restorative device intended to restore chewing function, which is a structural and mechanical function, not a therapeutic (treating disease) one.

Diagnostic

No.
The document describes a dental restorative device (screwed-retained bridge and bar) used for restoring chewing function in edentulous jaws, not a device for diagnosing a medical condition.

SaMD (Software as a Medical Device)

The device is a physical dental restorative device (bars and bridges made of titanium) that is manufactured using CAD/CAM technology based on scan data. While software is involved in the design process, the device itself is a physical implant component, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to restore chewing function by providing bars and bridges that attach to dental implants. This is a mechanical and structural function within the body.
Device Description: The device is a dental restorative device, specifically a screw-retained bridge or bar made of titanium, designed to be attached to dental implants. It is fabricated based on a scan of a dental model and a dentist's prescription.
Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease or condition, or to provide information about a patient's health status through in vitro examination of specimens.
Performance Studies: The performance studies focus on mechanical properties like fatigue testing and metal-ceramic bond strength, which are relevant to the structural integrity and function of a dental restoration, not diagnostic accuracy.

IVD devices are typically used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device is a physical implantable/restorative device used directly in the patient's mouth.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

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

Product codes (comma separated list FDA assigned to the subject device)

NHA

Device Description

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 Ti and Straumann CARES Dolder Bar Ti is designed the digital dataset is sent to Straumann CADCAM by internet connection where the bridge or bar is milled from a Titanium-based blank.

Straumann CARES Screw-retained Bridge Ti and Straumann CARES Dolder Bar Ti 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 CADderived, CAM-produced and have a scanner as its data source.

The milling blanks used for the manufacture of Straumann CARES Screwretained Bridge Ti and Straumann CARES Dolder Bar Ti are manufactured from Titanium, grade 4, which is biocompatible for its intended use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

edentulous jaws

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dental technician, dentist, dental laboratory

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)

Verification and validation testing were performed to ensure that the devices subject to this 510(k) Premarket Notification function as intended and that design input matches design output. Testing included:

Performance Testing
i. Fatigue Testing was performed utilizing pertinent testing procedures defined in the FDA guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments," and ISO 14801:2007, "Dentistry-Implants-Dynamic fatigue test for endosseous dental implants."
Tests performed and results:
- Minimal body testing: Passed (Meet or Exceed Predicate Device)
- Free hanging bridge: Passed (Meet or Exceed Predicate Device)
- Free end pontic bridge: Passed (Meet or Exceed Predicate Device)
  ii. Metal-Ceramic bond testing in accordance with ISO 9693: Metal-ceramic dental restorative systems: requirements satisfied.

The results from the testing conducted demonstrated that the Straumann CARES Screw-retained Bridge Ti and Straumann CARES Dolder Bar Ti functions as intended and met the pre-determined acceptance criteria.

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.

K101465, Straumann® CARES® Screw-retained Bridge and . Straumann® CARES® Dolder® Bar

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.

Not Found

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

Regulation Number and Section

§ 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.)

Summary

K//2280
NOV 16 2011

Image /page/0/Picture/1 description: The image shows the Straumann logo. The logo consists of a stylized graphic to the left of the word "straumann" in bold, sans-serif font. The graphic appears to be two parallel lines, each with three small squares within them.

510(k) Summary

1. Applicant's Name and Address

Straumann US (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 800-448-8168, ext 2513 Telephone Number: Fax Number: 978-747-0023 Contact Person: Elaine Alan Senior Regulatory Affairs Specialist

1. Date of Submission: August 8, 2011

3. Name of the Device

Straumann® CARES® Screw-retained Bridge Ti Trade Name: Straumann® CARES® Dolder® Bar Ti Common Name: Implant Bridge Classification Name: Endosseous Dental Implant Abutment Regulation Number: $872.3630

1. Legally Marketed Device to which Equivalence is Claimed (Predicate Device)
- K101465, Straumann® CARES® Screw-retained Bridge and . Straumann® CARES® Dolder® Bar

5. Description of the Device

6. Intended Use

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

The Straumann CARES Screw-retained Bridge Ti can be designed for specific patient sizes and spans that are attached to 2 to16 implants.

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

7. Technological Characteristics

The Straumann CARES Screw-retained Bridge Ti and Straumann CARES Dolder Bar Ti are equivalent to the predicate device in design, fundamental operating principles, and intended use. Table 1 compares the Straumann CARES Screw-retained Bridge and Straumann CARES Dolder Bar to the predicate device. The proposed devices are milled from blank discs of Titanium, grade 4, which is widely used in the medical industry and is well known to be biocompatible. The Straumann CARES Screw-retained Bridge Ti and Straumann CARES Dolder Bar Ti are designed using Straumann's CAD designing software, Straumann CARES® Visual®, and CAM milled at Straumann's central milling centers. This is the identical CADCAM designing and milling process as the predicate device.

Table 1: Comparison Matrix

| Feature | Proposed Device
Straumann CARES Screw-retained
Bridge Ti and
Straumann CARES Dolder Bar Ti | Predicate Device
Straumann CARES Screw-retained
Bridge and
Straumann CARES Dolder Bar |
|---------------|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Subject Submission | K101465 |
| Intended Use | Same | 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
Regular Neck (RN) Ø4.8mm and
Wide Neck (WN) 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 |

Feature	Proposed Device	Predicate Device
	Straumann CARES Screw-retained
Bridge Ti and
Straumann CARES Dolder Bar Ti	Straumann CARES Screw-retained
Bridge and
Straumann CARES Dolder Bar
Material	Titanium, grade 4	Coron, Cobalt-Chromium alloy
Implant
Compatibility	same	Straumann Regular Neck (RN)
Ø4.8mm and Wide Neck (WN)
Ø6.5mm
Design
Software	Same	Straumann CARES Visual
Basal Screw	Same	Titanium Alloy, Ti6Al7Nb

The proposed devices are substantially equivalent to the currently marketed predicate devices.

8. Performance Testing

1. Performance Testing
- i. Fatigue Testing was performed utilizing pertinent testing procedures defined in the FDA guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments," and ISO 14801:2007, "Dentistry-Implants-Dynamic fatigue test for endosseous dental implants." Table 2 lists tests performed and results.

Test Performed	Acceptance Criteria	Result
Minimal body testing	Meet or Exceed
Predicate Device	Passed
Free hanging bridge	Meet or Exceed
Predicate Device	Passed
Free end pontic bridge	Meet or Exceed
Predicate Device	Passed

Table 2

ii. Metal-Ceramic bond testing in accordance with ISO 9693: Metal-ceramic dental restorative systems: requirements satisfied.

Conclusion 9.

The Straumann CARES Screw-retained Bridge Ti and Straumann CARES Dolder Bar Ti is a validated device. The results of the performance bench testing and risk analysis indicate that the Straumann CARES Screwretained Bridge Ti and Straumann CARES Dolder Bar Ti is substantially equivalent to the identified predicate device and is safe and effective for its intended use.

Image /page/5/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is black. The text is likely part of a document or presentation.

Public Health Service

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

NOV 1 6 2011

Ms.Elaine Alan Senior Regulatory Affairs Specialist Straumann USA 60 Minuteman Road Andover, Massachusetts 01810 `

Re: K112280

Trade/Device Name: Straumann® CARES® Screw-retained Bridge Titanium Straumann® CARES® Dolder® Bar Titanium Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 14, 2011 Received: October 17, 2011

Dear Ms. Alan:

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. 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.

Page 2 – Ms. Alan

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

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

K/12280

Indications for Use

510(k) Number (if known):

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

Indications for Use:

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

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

X 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 Evaluation (ODE)

Susan Turner

Page 1 of 1

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K112081

510(k): Straumann SRBB Titanium