LEGACY3 6MM LENGTH IMPLANTS

K131097 · Implant Direct Sybron Manufacturing, LLC · DZE · Aug 22, 2013 · Dental

Device Facts

• Record ID: K131097
• Device Name: LEGACY3 6MM LENGTH IMPLANTS
• Applicant: Implant Direct Sybron Manufacturing, LLC
• Product Code: DZE · Dental
• Decision Date: Aug 22, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Legacy3 6mm Length implants consist of two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

Device Story

Legacy3 6mm implants are two-piece, root-form dental implants; designed for one-stage or two-stage surgical procedures in edentulous jaws. Features tapered body with double-lead buttress threads and quadruple-lead coronal threads; facilitates insertion in undersized sockets to enhance initial stability. Available in multiple diameters (3.7–7.0 mm) with Soluble Blasted Media (SBM) or HA-coated surfaces. Internal connection utilizes leading bevel, hex, and 1-72UNF thread. Used by dental surgeons in clinical settings to support single/multiple-unit restorations or fixed bridgework. Output is a stable foundation for prosthetic components; aids in restoring masticatory function for patients where longer implants are anatomically unsuitable. Device is a line extension of previously cleared Legacy implants; maintains prosthetic compatibility with existing surgical armamentaria.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by bench testing, including static compression, fatigue, implant driving torque, and abutment/screw torque-to-failure tests per ISO 14801 and FDA guidance. Comparative 3D CAD modeling and pull-out testing in simulated bone were used to demonstrate equivalent osseointegration surface area and retention.

Technological Characteristics

Material: Titanium Alloy (Ti 6AL-4V ELI). Design: Threaded, root-form, two-piece implant. Surface: SBM (Soluble Blasted Media) or HA-coated. Dimensions: 6mm length; 3.7–7.0mm diameters. Connection: Internal hex with 1-72UNF thread. Sterilization: Gamma irradiation (ISO 11137-2, AAMI TIR-33).

Indications for Use

Indicated for partially and fully edentulous upper and lower jaws in adults requiring single or multiple-unit restorations or terminal/intermediate abutment support for fixed bridgework; suitable for immediate loading given sufficient primary stability and appropriate occlusal loading.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Spectra Dental Implant System (K061319)
• Implant Direct Legacy Dental Implants with HA Coating (K073033)
• Implant Direct Spectra-System Implants 2008 (K090234)
• Implant Direct SwissPlant Implants (K081396)
• Bicon Implants with a 2.5mm Internal Connection (K092035)
• The Bicon 5.0 X 5.0mm and 6.0 X 5.0mm Dental Implant (K073368)
• ITI Dental Implant System (K030007)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows two logos side by side. The first logo is for Implant Direct, with the words "Implant Direct" in bold black letters. The second logo contains the text "Legacy3 6mmL Implants" in black letters.

# 510(K) Summary (21CFR 807.92(c))

- 1. Submitter's Information: Company Name: Implant Direct Sybron Manufacturing LLC 27030 Malibu Hills Rd., Calabasas Hills, CA USA 91301 Address: Telephone: [phone] Fax: [phone] Registration No .: Ines Aravena Contact: May 15, 2013 Date Prepared:
- 2. Device Name and Classification: Device Trade Name: Legacy3 6mm Length Implants Classification Names: Implant, Endosseous, Root-Form Endosseous Dental Implant Common Names: Requlation Number: 872.3640 Product Codes: DZE Regulatory Class: Il

AUG 2 2 2013

### 3. Predicate Device(s):

Spectra Dental Implant System (K061319) Implant Direct Legacy Dental Implants with HA Coating (K073033) Implant Direct Spectra-System Implants 2008 (K090234) Implant Direct SwissPlant Implants (K081396) Bicon Implants with a 2.5mm Internal Connection (K092035) The Bicon 5.0 X 5.0mm and 6.0 X 5.0mm Dental Implant (K073368) ITI Dental Implant System (K030007)

### 4. Device Description:

The Legacy3 6mm length implants consists of two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

The Legacy3 6mm length implants have a taper body to facilitate insertion in an undersized socket and gradual expansion of bone to increase initial stability. The body has double-lead buttress threads and quadruple-lead threads in the coronal

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# K131097

Image /page/1/Picture/1 description: The image shows the logo for Implant Direct. The logo is black and white and features the company name in a bold, sans-serif font. To the right of the logo, the text "Legacy3 6mmL Implants" is visible. The text is smaller than the logo and is also in black and white.

510(K) Submission

region. The body offers two surface options: Soluble Blasted Media (SBM) texture throughout the entire length or SBM at the coronal section plus HAcoated the rest of the body length. The internal connection consists of leading bevel, a hex and a 1-72UNF thread to engage the mating components.

The Legacy3, 6mm length implants are a line extension to the previously cleared Legacy implants (K090234) having identical prosthetic interface compatibility. The addition is not due to recall, customer complaint, corrective action, or labeling and it does not affect its intended use. The addition provides a shorter version of the predicate implant in order to allow for a restoration option in areas of the mouth where an 8mm implant will not work.

The shorter version required minor changes to the outer body design taper and threads depth to allow for adequate thread engagement when using existing surgical protocol and have a surface area that is equal or greater than the predicate devices. The shorter 6mm length implants are equivalent to the existing SwishPlant 6mm implants (K081396) with clinically proven safety and efficacy.

The Legacy3 6mmL implants offer six body diameters (3.7, 4.2, and 4.7, 5.2, 5.7 and 7.0 mm) in 6mm length with the platform diameter of 3.5, 4.5 and 5.7mm. The Legacy3 6mmL implants are available with two surface coatings: SBM Blast and HA Coating. The Legacy3 6mm implants are surgically and functionally compatible with the previously cleared prosthetic components (K060063, K081101, K090234 and K061319), and currently marketed laboratory components and surgical armamentaria.

### 5. Intended Use:

Legacy3 6mm Length implants consist of two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

### Device Comparison (Technological Characteristics): 6.

This submission is comprised of devices whose physical dimensions, material composition, indications for use and methods of manufacture were previously cleared and have the same principles of operation as the cited predicate devices. The following Tables summarize the predicate device comparison analyses with the devices within the Legacy3 6mmL Implants. The subject device and the predicate devices have the same intended, the same technological characteristics, implant/abutment interface, similar material and surface treatment.

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Image /page/2/Picture/1 description: The image contains two distinct text blocks. The first block features the logo of "Implant Direct," accompanied by smaller text underneath. The second block reads "Legacy3 6mmL Implants", indicating a specific product or model. The text is clear and legible, suggesting a label or product description.

The table below compares the Legacy3 6mm Length Implants with currently marketed products. The comparison analysis consisted of the products' technological characteristics and intended use to support the substantial equivalency to their corresponding predicate devices.

### Device Comparison Table: Legacy3 6mmL Dental Implants

| Characteristics | Proposed:<br>Legacy3 6mm | Own Predicate<br>Device: Legacy<br>8mm<br>(K073033,<br>K090234) | Own Reference<br>Device:<br>SwissPlant 6mm<br>(K081396) | Predicate<br>Device:<br>Bicon<br>Implants<br>(K073368<br>and<br>K092035) | Predicate<br>Device:<br>Straumann<br>(K030007) | Substantial<br>Equivalence |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Part<br>Numbers | 853706, 854206,<br>854706, 855206,<br>855706, 857008,<br>863706, 864206,<br>864706, 865206,<br>865706, 867008 | 853208, 853708,<br>854208, 854708,<br>855208, 855708,<br>857008 | 904106, 904806,<br>904806W,<br>905706 | 260-340-255 | 043.051S | √ |
| Intended<br>Use | The Legacy<br>Dental Implant is<br>a dental implant<br>fixture that is a<br>part of a two-<br>piece implant<br>system. The<br>Legacy implants<br>are intended for<br>use in the<br>mandible and<br>maxilla, in<br>support of single<br>or multiple-unit<br>cement or screw<br>receiving fixed<br>restorations and<br>for retention and<br>support of<br>overdentures.<br>The implants are<br>intended for<br>immediate<br>placement and | The Legacy<br>Dental Implant is<br>a dental implant<br>fixture that is a<br>part of a two-<br>piece implant<br>system. The<br>Legacy implants<br>are intended for<br>use in the<br>mandible and<br>maxilla, in<br>support of single<br>or multiple-unit<br>cement or screw<br>receiving fixed<br>restorations and<br>for retention and<br>support of<br>overdentures.<br>The implants are<br>intended for<br>immediate<br>placement and | The SwissPlant<br>Dental Implant<br>system consists<br>of two-piece<br>implants for one<br>or two-stage<br>surgical<br>procedures that<br>are intended for<br>use in partially or<br>fully edentulous<br>mandibles and<br>maxillae, in<br>support of single<br>or multiple-unit<br>restorations<br>including: cement<br>retained, screw<br>retained or<br>overdenture<br>restorations and<br>in terminal or<br>immediate<br>abutment support | Intended for<br>surgical<br>implantation<br>in edentulous<br>mandibles or<br>maxillae for<br>attachment of<br>complete<br>denture<br>prostheses,<br>or as a<br>terminal or<br>intermediary<br>attachment<br>for fixed or<br>removable<br>bridgework,<br>or as a<br>freestanding<br>single tooth<br>replacement | Intended for<br>immediate<br>placement<br>and function<br>on single-<br>tooth and/or<br>multiple tooth<br>applications<br>when good<br>primary<br>stability is<br>achieved and<br>with<br>appropriate<br>occlusal<br>loading, to<br>restore<br>chewing<br>function.<br>Multiple tooth<br>applications<br>may be<br>rigidly<br>splinted. In | √ |
| | | | | | 510(K) Submission | |
| | function for<br>support of single<br>tooth and/or<br>multiple tooth<br>restorations,<br>recognizing bone<br>stability and<br>appropriate<br>occlusal load<br>requirements. | function for<br>support of single<br>tooth and/or<br>multiple tooth<br>restorations,<br>recognizing bone<br>stability and<br>appropriate<br>occlusal load<br>requirements. | for fixed<br>bridgework. The<br>SwissPlant dental<br>implants are<br>intended for<br>immediate<br>placement and<br>function on single<br>tooth and/or<br>multiple tooth<br>applications<br>recognizing initial<br>implant stability<br>and appropriate<br>occlusal loading,<br>to restore normal<br>masticatory<br>function. | | case of<br>edentulous<br>patients 4 or<br>more<br>implants<br>must be used | |
| Indication | Immediate Load | Immediate Load | Immediate Load | Unknown | Unknown | √ |
| General<br>Design | Threaded, root<br>form implant | Threaded, root<br>form implant | Threaded, root<br>form implant | Groove type<br>implant | Threaded,<br>root form<br>implant | √ |
| Placement<br>Method | Dual or single-<br>stage surgery | Dual or single-<br>stage surgery | Dual or single-<br>stage surgery | Two or single<br>stage surgery | Single stage<br>surgery | √ |
| Material | Titanium Alloy (Ti<br>6AL-4V ELI) | Titanium Alloy (Ti<br>6AL-4V ELI) | Titanium Alloy (Ti<br>6AL-4V ELI) | Commercially<br>pure Titanium | Commercially<br>pure Titanium | √ |
| Implant<br>Body | Threaded body<br>without gingival<br>collar | Threaded body<br>without gingival<br>collar | Threaded body<br>with gingival<br>collar | Grooved<br>body without<br>gingival collar | Threaded<br>body with<br>gingival collar | √ |
| Body<br>Diameter | 3.7, 4.2, 4.7, 5.2,<br>5.7, 7.0mm | 3.2, 3.7, 4.2, 4.7,<br>5.2, 5.7, 7.0mm | 4.1, 4.8, 5.7mm | 4.0, 5.0,<br>6.0mm | 4.1, 4.8mm | √ |
| Length | 6mm | 8mm | 6mm | 5mm | 6mm | √ |
| Platform<br>Diameter | 3.5, 4.5, 5.7mmD<br>853706, 863706,<br>854206 & 864206<br>- Ø3.5 platform<br>854706, 864706,<br>855206 & 865206<br>- Ø4.5 platform<br>855706, 865706,<br>857006 & 867006<br>- Ø5.7 platform | 3.0,3.5, 4.5,<br>5.7mmD<br>853208 =<br>Ø3.0 platform<br>853708 & 854208<br>- Ø3.5 platform<br>854708 & 855208<br>- Ø4.5 platform<br>855708 & 857008<br>- Ø5.7 platform | 4.8, 6.5mmD<br>904106 & 904806<br>-Ø4.8mm platform<br>904806W &<br>905706<br>-Ø6.5mm platform | 2.5 - 3.0mm | 4.8 and<br>6.5mm | √ |
| Implant<br>Surface | SBM | SBM | SBM | Integra-Ti<br>and Integra-CP | SLA and<br>SLActive | √ |
| level | Roughened | Roughened | Roughened or<br>Dual Roughened | Unknown | Unknown | |
| Surface<br>Roughness | SBM =1.5-2.3μm | SBM =1.5-2.3μm | SBM =1.5-2.3μm | Unknown | Unknown | √ |
| Packaging | Inner sleeve to<br>suspend the<br>implant/fixture-<br>mount assembly<br>inside an outer<br>vial sealed with a<br>cap. Packaging<br>also includes<br>surgical cover<br>screw, extender<br>and temporary<br>coping | Inner sleeve to<br>suspend the<br>implant/fixture-<br>mount assembly<br>inside an outer<br>vial sealed with a<br>cap. Packaging<br>also includes<br>surgical cover<br>screw, extender<br>and temporary<br>coping | Inner sleeve to<br>suspend the<br>implant/fixture-<br>mount assembly<br>inside an outer<br>vial sealed with a<br>cap. Packaging<br>also includes<br>surgical cover<br>screw, extender<br>and temporary<br>coping | Implants are<br>packaged in<br>a sealed<br>plastic<br>container<br>with a Tyvek<br>type sealed<br>barrier and<br>with a plastic<br>carrier. | Double vial<br>system.<br>Inner sleeve<br>to suspend<br>the implant<br>inside an<br>outer vial<br>sealed with a<br>cap.<br>Packaging<br>also includes<br>surgical<br>cover screw | √ |
| Sterilizatio<br>n | Gamma<br>Irradiation | Gamma<br>Irradiation | Gamma<br>Irradiation | Unknown | Unknown | √ |
| 510(k)<br>Number | | K073033<br>K090234 | K081396 | K073368<br>K092035 | K030007 | √ |

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K131097

Image /page/3/Picture/1 description: The image contains two distinct sections. The left side features the logo for "Implant Direct", with the text arranged in a specific font and layout. The right side of the image contains the text "Legacy3 6mmL Implants", which appears to be a product description or label.

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The Legacy3 6mmL implants were shown to be substantially equivalent to the predicate devices: Legacy 8mmL (K073033 and K090234), SwissPlant 6mmL Implants (K081396), Bicon Implants (K073368 and K092035), and Straumann Implants (K030007).

### Non-clinical Performance Testing: 7.

The devices in this submission have mechanical safety (strength) equivalent to the predicate devices. Laboratory testing was conducted for the worst-case devices following FDA "Class II Special Control Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801 in static compression bending and fatigue, as well as implant driving torque and abutment/screw torque to failure tests. The components have shown to exhibit equivalent mechanical strength as the predicate devices and the implant/abutment combinations were able to withstand loads that were higher than the functional masticatory loads.

In addition, comparative surface area analysis was performed to demonstrate substantial equivalence by creating 3D models of the implants and obtaining the total external osseointegration surface area using three dimensional CAD measurement function. Furthermore, comparative pull-out testing was conducted

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| | Concession Company of Children |
|-------|--------------------------------|
| : Com | Legacy3 6mmL Implants |

to demonstrate substantial equivalence by inserting the implants into simulated bone taking into account 3mm of potential bone loss.

Lastly, sterilization Validation was carried out in accordance with ISO 11137-2 and AAMI TIR-33 for gamma radiation.

#### 8. Clinical Performance Testing

No clinical testing was performed. The clinical evaluation was used to support the decision of safety and effectiveness.

#### 9. Conclusion:

The information submitted in this 510(k) for the Legacy3 6mmL Implants have shown that the devices are substantial equivalent to the device systems identified as predicates and it is considered that the new devices are as safe and effective for its indication for use, compatible and performs as well the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with outstretched wings, rendered in black lines. The bird is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged around the upper portion of the circle. The text is also in black and appears to be in all capital letters.

August 22, 2013

Implant Direct Sybron Manufacturing LLC Ms. Ines Aravena Senior Director of Product Design and Regulatory Affairs 27030 Malibu Hills Road CALABASAS HILLS CA 91301

K131097 Re:

Trade/Device Name: Legacy3 6mm Length Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: July 23, 2013 Received: July 24, 2013

Dear Ms. Aravena:

We have reviewed your Section 510(k) premarket notification of intent to referenced above and have determined the device is substantially equivale for use stated in the enclosure) to legally marketed predicate devices mark commerce prior to May 28, 1976, the enactment date of the Medical Device devices that have been reclassified in accordance with the provisions of the and Cosmetic Act (Act) that do not require approval of a premarket appro You may, therefore, market the device, subject to the general controls pro general controls provisions of the Act include requirements for annual reg devices, good manufacturing practice, labeling, and prohibitions against n International Places not ... CDD11 dage not sucluate information ralatad to

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Please be advised that FDA's issuance of a substantial equivalence determ that FDA has made a determination that your device complies with other r or any Federal statutes and regulations administered by other Federal agen comply with all the Act's requirements, including, but not limited to: regis CFR Part 807); labeling (21 CFR Part 801); medical device reporting (rep device-related adverse events) (21 CFR 803); good manufacturing practice forth in the quality systems (QS) regulation (21 CFR Part 820); and if app product radiation control provisions (Sections 531-542 of the Act); 21 CFI

If you desire specific advice for your device on our labeling regulation (21 contact the Division of Small Manufacturers, International and Consumer free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.ht the regulation entitled. "Misbranding by reference to premarket notificatio 807.97). For questions regarding the reporting of adverse events under the CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm f of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under t Division of Small Manufacturers, International and Consumer Assistance [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.ht

Sincerely yours,

Image /page/7/Picture/5 description: The image shows the name "Mary S. Ru". The text is in a bold, sans-serif font. The letters are black, and the background is white. The letters are slightly distorted, especially the "S" and "Ru".

Y II VIA

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Image /page/8/Picture/0 description: The image contains two logos. The first logo is for "Implant Direct Sybron Dental Specialties". The second logo is for "Legacy3 6mmL Implants".

## Indications for Use

510(k) Number (if known): K131097

Device Name: Legacy3 6mm Length_Implants

Indications for Use:

Legacy3 6mm Length consists of two-picce implants for one-stage on two-stage surgical Legacy3 bmm Lengin consists of Norpheee napitally and fully edentulous upper
procedures. These implants are intended for use in partially and fully as any procedures. These miffams are miended this are restorations and serminal or intermediate abutment support for fixed bridgework. Implants can be indicated for intermediate abutifiem support for fixed bridgeworks aspirities and with appropriate occlusal loading.

Prescription Use _ メ (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Andrew I. Steen -S-2013.08.21 08:05:01 -04'00'

Division Sign-Off) ·ivision of Anesthesiology, General Hospital rection Control, Dental Devices

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510(k) Number: 长13(0分7