K Number
K111357
Device Name
STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM
Manufacturer
Date Cleared
2011-10-03

(140 days)

Product Code
Regulation Number
872.3640
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Straumann® dental implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). When placing implants in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases. Specific indications for small diameter (Ø 3.3 mm) implants: Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended. Straumann Narrow Neck CrossFit® (NNC) Gold Abutment for Crowns Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Straumann Narrow Neck CrossFit® (NNC) Temporary Abutments The Straumann NNC Temporary Abutments are indicated for use in Straumann NNC Tissue Level Implants for temporary restorations of single crowns and bridges for up to six months. Straumann Narrow Neck CrossFit® (NNC) Healing Caps and Closure Screws Straumann NNC Healing Caps and NNC Closure Screws are intended for use with the Straumann NNC Tissue Level Implant System to protect the inner configuration of the implant. Healing Caps have a secondary function to maintain, stabilize and form the soft tissue during the healing process.
Device Description
The proposed Straumann Narrow Neck Connection CrossFit® (NNC) Ø3.3mm Dental Implant System is a new product to be added to our current Tissue Level implant product portfolio. Straumann currently has a Tissue Level dental implant with a Ø3.5mm prosthetic platform with an external hexagon abutment; the abutment and implant are machined as one piece. The proposed system introduces a Ø3.5mm prosthetic platform with an internal CrossFit connection. The proposed system is an implant with no attached abutment. The abutment is sold separately. The purpose of this 510(k) Premarket Notification is to introduce: - Narrow Neck CrossFit® (NNC) Ø3.3mm dental implant in 4 lengths; a. 8.0mm, 10.0mm, 12.0mm and 14.0m, - b. Gold abutment for use with the crown, - c. NNC posts for temporary restorations made from Titanium. The posts are to be used for a single crown restoration or bridge, - d. NNC closure screws (0mm and 1.5mm), - e. Healing caps (3.0mm, 4.5mm and 2.0mm), - f. NNC impression post, open tray, and - g. NNC analog. The body of the proposed implant has a threaded Ø3.3mm implant body design with the SLActive surface of Straumann's TiZr Implant currently cleared under K083550. The material of the proposed implant is Straumann's Titanium Zirconium (TiZr) currently cleared under K083550. This design proposes a narrow Tissue Level implant with an internal connection for smaller interdental spaces.
More Information

Not Found

No
The summary describes a physical dental implant system and its components, with no mention of software, algorithms, or AI/ML capabilities.

No
The device is a dental implant system used for oral rehabilitation, which is a restorative rather than therapeutic function. It replaces missing teeth, but does not treat a disease or condition in the way a therapeutic device would.

No

The device description clearly states that these are dental implants and related components (abutments, screws, caps) used for oral rehabilitation, restoring chewing function, and providing support for prosthetic reconstructions. There is no mention of the device being used to diagnose a medical condition or disease.

No

The device description explicitly details physical components such as dental implants, abutments, closure screws, and healing caps, and the performance testing involves fatigue testing of these physical devices. There is no mention of software as a component of the device.

Based on the provided text, 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 Description and Intended Use: The description and intended use clearly state that this device is a dental implant system designed for surgical implantation into the jawbone to support prosthetic restorations like crowns, bridges, and dentures. This is an in vivo application (within the living body), not an in vitro application (outside the living body).
  • Lack of IVD Characteristics: The text does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes.

Therefore, this device falls under the category of a surgical implant and associated components, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

Straumann® dental implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). When placing implants in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.

Specific indications for small diameter (Ø 3.3 mm) implants: Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended.

Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.

The Straumann NNC Temporary Abutments are indicated for use in Straumann NNC Tissue Level Implants for temporary restorations of single crowns and bridges for up to six months.

Straumann NNC Healing Caps and NNC Closure Screws are intended for use with the Straumann NNC Tissue Level Implant system to protect the inner configuration of the implant. Healing Caps have a secondary function to maintain, stabilize and form the soft tissue during the healing process.

Product codes

DZE

Device Description

The proposed Straumann Narrow Neck Connection CrossFit® (NNC) Ø3.3mm Dental Implant System is a new product to be added to our current Tissue Level implant product portfolio. Straumann currently has a Tissue Level dental implant with a Ø3.5mm prosthetic platform with an external hexagon abutment; the abutment and implant are machined as one piece.

The proposed system introduces a Ø3.5mm prosthetic platform with an internal CrossFit connection. The proposed system is an implant with no attached abutment. The abutment is sold separately.

The purpose of this 510(k) Premarket Notification is to introduce:

  • Narrow Neck CrossFit® (NNC) Ø3.3mm dental implant in 4 lengths;
    a. 8.0mm, 10.0mm, 12.0mm and 14.0m,
  • b. Gold abutment for use with the crown,
  • c. NNC posts for temporary restorations made from Titanium. The posts are to be used for a single crown restoration or bridge,
  • d. NNC closure screws (0mm and 1.5mm),
  • e. Healing caps (3.0mm, 4.5mm and 2.0mm),
  • f. NNC impression post, open tray, and
  • g. NNC analog.

The body of the proposed implant has a threaded Ø3.3mm implant body design with the SLActive surface of Straumann's TiZr Implant currently cleared under K083550. The material of the proposed implant is Straumann's Titanium Zirconium (TiZr) currently cleared under K083550. This design proposes a narrow Tissue Level implant with an internal connection for smaller interdental spaces. There are no changes to the materials, indications for use, fundamental operating principles, or sterilization processes or procedures as a result of the new implant and its accessories and components. No new surgical instruments are being introduced as placement of the proposed implant will follow the established surgical protocols of the currently cleared Straumann Dental Implant Systems. The proposed devices are substantially equivalent to the currently marketed devices. .

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper and lower jaw

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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:

    1. Performance Testing
    • a. Fatigue Testing in accordance to FDA guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments."

The results from the testing conducted demonstrated that the Straumann Narrow Neck CrossFit® (NNC) Ø3.3mm Dental Implant System functions as intended and met the pre-determined acceptance criteria.

The Straumann Narrow Neck CrossFit® (NNC) Ø3.3mm Dental Implant System is a validated system. The results of the performance bench testing and risk analysis indicate that the Straumann Narrow Neck CrossFit (NNC) Ø3.3mm Dental Implant System is substantially equivalent to the named predicate devices and is safe and effective for its intended use.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K083550, K060958, K072497, K092814, K071585, K960634

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

0

K111357

OCT - 3 2011

Applicant's Name and Address 1.

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

  • Date of Submission: May 12, 2011 2.

3. Name of the Device

| Trade Name: | Straumann Narrow Neck CrossFit® (NNC)
Ø3.3mm Dental Implant System |
|----------------------|-----------------------------------------------------------------------|
| Common Name: | NNC Ø3.3mm Dental Implant |
| Classification Name: | Implant, Endosseous, Root-form |
| Regulation Number: | §872.3640 |

Legally Marketed Device to which Equivalence is Claimed (Predicate 1. Device)

K083550. Straumann Dental Implant System K060958, Straumann Narrow Neck Dental Implants K072497, P.004 NC Gold Abutment for Crowns K092814. Straumann NC Temporary Abutments K071585, NC Closure Screws K960634, Esthetic Healing Caps

Description of the Device 5.

The proposed Straumann Narrow Neck Connection CrossFit® (NNC) Ø3.3mm Dental Implant System is a new product to be added to our current Tissue Level implant product portfolio. Straumann currently has a Tissue Level dental implant with a Ø3.5mm prosthetic platform with an external hexagon abutment; the abutment and implant are machined as one piece.

1

The proposed system introduces a Ø3.5mm prosthetic platform with an internal CrossFit connection. The proposed system is an implant with no attached abutment. The abutment is sold separately.

The purpose of this 510(k) Premarket Notification is to introduce:

  • Narrow Neck CrossFit® (NNC) Ø3.3mm dental implant in 4 lengths; a. 8.0mm, 10.0mm, 12.0mm and 14.0m,
  • b. Gold abutment for use with the crown,
  • c. NNC posts for temporary restorations made from Titanium. The posts are to be used for a single crown restoration or bridge,
  • d. NNC closure screws (0mm and 1.5mm),
  • e. Healing caps (3.0mm, 4.5mm and 2.0mm),
  • f. NNC impression post, open tray, and
  • g. NNC analog.

Intended Use of the Device 6.

Narrow Neck CrossFit® (NNC) Dental Implants

Straumann® dental implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). When placing implants in the posterior region, we recommend using only

2

large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.

Specific indications for small diameter (Ø 3.3 mm) implants: Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended.

Straumann Narrow Neck CrossFit® (NNC) Gold Abutment for Crowns Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.

Straumann Narrow Neck CrossFit® (NNC) Temporary Abutments

The Straumann NNC Temporary Abutments are indicated for use in Straumann NNC Tissue Level Implants for temporary restorations of single crowns and bridges for up to six months.

Straumann Narrow Neck CrossFit® (NNC) Healing Caps and Closure Screws

Straumann NNC Healing Caps and NNC Closure Screws are intended for use with the Straumann NNC Tissue Level Implant System to protect the inner configuration of the implant. Healing Caps have a secondary function to maintain, stabilize and form the soft tissue during the healing process.

7. Technological Characteristics

The body of the proposed implant has a threaded Ø3.3mm implant body design with the SLActive surface of Straumann's TiZr Implant currently

3

cleared under K083550. The material of the proposed implant is Straumann's Titanium Zirconium (TiZr) currently cleared under K083550. This design proposes a narrow Tissue Level implant with an internal connection for smaller interdental spaces. There are no changes to the materials, indications for use, fundamental operating principles, or sterilization processes or procedures as a result of the new implant and its accessories and components. No new surgical instruments are being introduced as placement of the proposed implant will follow the established surgical protocols of the currently cleared Straumann Dental Implant Systems. The proposed devices are substantially equivalent to the currently marketed devices. .

8. Performance Testing

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:

    1. Performance Testing
    • a. Fatigue Testing in accordance to FDA guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments."

9. Conclusion

The results from the testing conducted demonstrated that the Straumann Narrow Neck CrossFit® (NNC) Ø3.3mm Dental Implant System functions as intended and met the pre-determined acceptance criteria.

The Straumann Narrow Neck CrossFit® (NNC) Ø3.3mm Dental Implant System is a validated system. The results of the performance bench testing and risk analysis indicate that the Straumann Narrow Neck

4

CrossFit (NNC) Ø3.3mm Dental Implant System is substantially equivalent to the named predicate devices and is safe and effective for its intended use.

5

Image /page/5/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a sans-serif font. The text is black and is on a white background. There is a logo to the left of the text.

Image /page/5/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of three stylized human figures connected by flowing lines, representing the department's mission to protect the health of all Americans and provide essential human services.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 2093-0002

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

OCT = 3 201

Re: K111357

Trade/Device Name: Straumann Narrow Neck CrossFit (NNC) 03.3 Dental Implant System, Straumann Narrow Neck CrossFit (NNC) Gold Abutment for Crowns. Straumann Narrow Neck CrossFit (NNC) Temporary Abutments, Straumann -Narrow Neck CrossFit (NNC) Healing Caps and Closure Screws Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: August 19, 2011 Received: August 22, 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.

6

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/CentersOfTices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Fleath'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/Resourcesfor You/Industry/default.hum.

Sincerely yours.

hn 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

7

510(k) Number (if known):

Device Name: Narrow Neck CrossFit (NNC) Ø3.3mm Dental Implant System

Indications for Use:

Straumann® dental implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). When placing implants in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.

Specific indications for small diameter (Ø 3.3 mm) implants: Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended.

Prescription Use X (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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental DevicesPage 1 of 1
RE: 510(k) Straumann NNC
Dental Implant System
510(k) Number:K111357
May 13, 2011Page 16 of 126

8

510(k) Number (if known):

Device Name: Straumann Narrow Neck CrossFit (NNC) Gold Abutment for Crowns

Indications for Use:

Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.

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)

Division: State of Illinois

Page 1 of 1

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

510(k) Number: K111357

9

510(k) Number (if known):

Device Name: Straumann Narrow Neck CrossFit (NNC) Temporary Abutments

Indications for Use:

The Straumann NNC Temporary Abutments are indicated for use in Straumann NNC Tissue Level Implants for temporary restorations of single crowns and bridges for up to six months.

× 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)

Zl

Page 1 of 1

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

510(k) Number: K111357

10

510(k) Number (if known):

Device Name: Straumann Narrow Neck CrossFit (NNC) Healing Caps and Closure Screws

Indications for Use:

Straumann NNC Healing Caps and NNC Closure Screws are intended for use with the Straumann NNC Tissue Level Implant system to protect the inner configuration of the implant. Healing Caps have a secondary function to maintain, stabilize and form the soft tissue during the healing process.

× 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)

h

Page 1 of 1

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

510(k) Number: k 11357