(200 days)
Not Found
No
The summary describes a dental implant, a physical device, and its mechanical and clinical performance. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The device is described as "Dental Implants" which are surgically placed to restore chewing function and provide prosthetic attachment, indicating a therapeutic purpose to treat edentulous conditions.
No
This device is a dental implant intended for surgical placement and prosthetic attachment, not for diagnosing medical conditions.
No
The device description clearly states it is a physical dental implant made of titanium, which is a hardware component. The performance studies also focus on mechanical properties and clinical placement, not software performance.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant placed in the jaw to support dental prosthetics. This is a medical device used in vivo (within the body).
- Device Description: The description details the physical characteristics of a dental implant made of titanium, designed for surgical placement.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
BIOMET 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
OSSEOTITE® 2 Dental Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
OSSEOTITE® 2 Dental Implants are similar to predicate BIOMET 3i OSSEOTITE Implants, currently being sold worldwide. OSSEOTITE 2® Dental Implants are provided with the proprietary OSSEOTITE dual acid-etched surface which has been in commercial distribution since market clearance in 1995 and are made of Commercially Pure Titanium. Implants have a straight wall design, with an External Hex Connection. OSSEOTITE® 2 Dental Implants are offered in diameters of 3.25, 3.75, 4.0, 5.0, and 6.0 in varying lengths from 3 mm to 15 mm. Size appropriate cover screws are provided with each implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or 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)
Bench Testing: BIOMET 31 has conducted Design Verification Testing according to ISO 14801:2007 "Dentistry – Dynamic Fatigue Test for Endosseous Dental Implants'' on the OSSEOTITE® 2 Dental Implants under this submission. All testing conducted met the acceptance criteria and evaluated the worst case scenario including 30° pre-angled abutments as compared to predicate BIOMET 3i designs commercially in the marketplace. Performance testing data indicates that changes to the predicate device are safe and effective for its intended use and it demonstrate to be substantially equivalent. Bench Testing conducted demonstrates that the proposed device meets the mechanical properties recommendations by FDA and ISO Standards.
Clinical Data: Two clinical reports on OSSEOTITE® 2 Dental Implants are included with this submission:
- "Insertional Torque Force, Osseotite 2 Placement Data, ● Pressure Necrosis" dated September 21st, 2011. This report provides background information on the thread design for the OSSEOTITE® 2 Dental Implants and a summary of two clinical projects where insertion torque forces are measured. The report includes an analysis of the actual insertion torque forces for this implant design, the success of the implants at a defined follow-up time point post loading, and a review of the implant failures and their baseline torque values. Additionally, the subject of pressure necrosis that has been alluded with implant placement procedures associated with high insertion torque forces is discussed.
- "BIOMET 3i Insertion Torque Report", dated November 10, . 2011. This report provides an overview of the implant placement experience data for the OSSEOTITE® 2 Dental Implants, including a tabulation of individual insertion torque values and implant failures.
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.
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
§ 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
NOV 1 8 2011
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93
| Submitter: | BIOMET 3i
4555 Riverside Drive
Palm Beach Gardens, FL 33410 |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Reg. Number: | 1038806 |
| Contact: | Martha I Garay
Senior Regulatory Affairs Specialist
BIOMET 3i
4555 Riverside Drive
Palm Beach Gardens, FL 33410
Tel. 561-776-6923
Fax. 561-514 6316
Email martha.garay@BIOMET.com |
| Date Prepared: | November 18th, 2011 |
| Trade/Proprietary Name: | OSSEOTITE® 2 Dental Implants |
| Common/Usual Name: | Root-Form Endosseous Dental Implant |
| Classification Name/ FDA Reviewing Branch: | Endosseous Dental Implant / Dental Panel |
| Device Classification/Code: | Class II - 21 CFR §872.3640 / DZE |
| Predicate Device Manufacturer: | K100724 - OSSEOTITE II MODEL XIFOSSXXX / BIOMET 3i
K063286 – OSSEOTITE Dental Implants / BIOMET 3i |
| Purpose of the SPECIAL 510(k) notice: | The reason for this Special 510k submission is to request clearance for
modification to a device that has been cleared under the 510(k) process
referred to herein as OSSEOTITE® 2 Dental Implants. Root-Form
Endosseous Dental Implants are referenced under 21 CFR §872.3640
and are considered Class II devices. |
| Device Description: | OSSEOTITE® 2 Dental Implants are similar to predicate BIOMET 3i
OSSEOTITE Implants, currently being sold worldwide. OSSEOTITE
2® Dental Implants are provided with the proprietary OSSEOTITE dual
acid-etched surface which has been in commercial distribution since
market clearance in 1995 and are made of Commercially Pure Titanium. |
1
Implants have a straight wall design, with an External Hex Connection. OSSEOTITE® 2 Dental Implants are offered in diameters of 3.25, 3.75, 4.0, 5.0, and 6.0 in varying lengths from 3 mm to 15 mm. Size appropriate cover screws are provided with each implant.
BIOMET 3i Dental Implants are intended for surgical placement in the Indications for Use: upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
OSSEOTITE®2 Dental Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.
The predicates and OSSEOTITE® 2 Dental Implants have a number of very similar and equivalent design / technological characteristics, as follows:
| Criteria | Predicate
OSSEOTITE II
MODEL
XIFOSSXXX
(Internal Hex)
K100724 | Predicate
OSSEOTITE;
OSSEOTITE NT;
XP; TG Implant(s)
(External Hex)
K063286 | Proposed
OSSEOTITE® 2
Dental Implant(s)
(External Hex)
K111216 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Implant Lengths | Ø3.25: 8.5, 10.0,
11.5, 13.0, 15.0,
18.0mm
Ø4.0: 8.5, 10.0,
11.5, 13.0, 15.0,
18.0, 20.0mm
Ø5.0: 8.5, 10.0,
11.5, 13.0, 15.0mm
Ø6.0: 8.5, 10.0,
11.5, 13.0, 15.0mm | Ø3.25: 7
(actual:6.6mm), 8.5,
10, 11.5, 13, 15mm
Ø3.75: 7
(actual:6.6mm),, 8.5,
10, 11.5, 13, 15mm
Ø4: 7
(actual:6.6mm),, 8.5,
10, 11.5, 13, 15mm
Ø5: 7
(actual:6.6mm),, 8.5,
10, 11.5, 13, 15mm
Ø6: 7
(actual:6.6mm),, 8.5,
10, 11.5, 13, 15mm | Ø3.25: 6.5, 8.5, 10,
11.5, 13, 15mm
Ø3.75: 6.5, 8.5, 10,
11.5, 13, 15mm
Ø4: 6.5, 8.5, 10,
11.5, 13, 15mm
Ø5: 6.5, 8.5, 10,
11.5, 13, 15mm
Ø6: 6.5, 8.5, 10,
11.5, 13, 15mm |
| Implant Body
Diameters | Ø3.25, 4.0, 5.0,
6.0mm | Ø3.25, 3.75, 4, 5,
6mm | Ø3.25, 3.75, 4, 5,
6mm |
| Seating Platform
Diameter | Ø3.25: 3.4mm
Ø4: 4.1mm
Ø5: 5.0mm
Ø6: 6.0mm | Ø3.25: 3.4mm
Ø3.75: 4.1mm
Ø4: 4.1mm
Ø5: 5.0mm
Ø6: 6.0mm | Ø3.25: 3.4mm
Ø3.75: 4.1mm
Ø4: 4.1mm
Ø5: 5.0mm
Ø6: 6.0mm |
| Material | Commercially Pure
Titanium | Commercially Pure
Titanium | Commercially Pure
Titanium |
Technological Characteristics :
2
111216
| Biocompatible | Yes | Yes | Yes |
|---|---|---|---|
| Thread Design | • 60° thread & | ||
| 0.6mm pitch | |||
| (Straight-Wall) | |||
| • 35° thread & | |||
| 0.8mm pitch | |||
| (Straight-Wall) | • 60° thread & | ||
| 0.6mm pitch | |||
| (Straight-Wall) | |||
| • 60° thread & | |||
| 0.9mm pitch | |||
| (Straight-Wall) | • 60° thread & | ||
| 0.6mm pitch | |||
| (Straight-Wall) | |||
| • 35° thread & | |||
| 0.8mm pitch | |||
| (Straight-Wall) | |||
| Implant Design | Straight-walled | ||
| implant body | Straight-walled | ||
| implant body | Straight-walled | ||
| implant body | |||
| Self Tapping | |||
| Feature | Integrated cutting | ||
| flutes with apical | |||
| taper | Integrated cutting | ||
| flutes with apical | |||
| taper | Integrated cutting | ||
| flutes with apical | |||
| taper | |||
| Implant Surface | Full OSSEOTITE® | Full OSSEOTITE® | Full OSSEOTITE® |
| Color-Coding | • Anodized Seating | ||
| Surface | |||
| • Color-Coded | |||
| Labeling | • Anodized Seating | ||
| Surface | |||
| • Color-Coded | |||
| Labeling | • Anodized Seating | ||
| Surface | |||
| • Color-Coded | |||
| Labeling | |||
| Packaging | Packaged in sterile | ||
| tray with cover | |||
| screw | Packaged in sterile | ||
| tray with cover screw | Packaged in sterile | ||
| tray with cover | |||
| screw | |||
| Sterilization | Sterile (Gamma | ||
| Irradiation) | Sterile (Gamma | ||
| Irradiation) | Sterile (Gamma | ||
| Irradiation) | |||
| Shelf Life | 5 Years | 5 Years | 5 Years |
| Implant | |||
| Placement | |||
| Protocol | Per BIOMET 3i | ||
| Surgical Catalog | |||
| CATSM | Per BIOMET 3i | ||
| Surgical Catalog | |||
| CATSM | Per BIOMET 3i | ||
| Surgical Catalog | |||
| CATM2 | |||
| Implant/Abutment | |||
| Mating | |||
| Connection | Internal Hexagon | ||
| Connection | External Hexagon | ||
| Connection | External Hexagon | ||
| Connection | |||
| Mating | |||
| Components | All BIOMET 3i | ||
| Certain® | |||
| Restorative | |||
| Components | All BIOMET 3i | ||
| External Hex | |||
| Restorative | |||
| Components | All BIOMET 3i | ||
| External Hex | |||
| Restorative | |||
| Components |
Performance Data:
Clinical Data:
BIOMET 31 has conducted Design Verification Testing according to ISO 14801:2007 "Dentistry – Dynamic Fatigue Test for Endosseous Dental Implants'' on the OSSEOTITE® 2 Dental Implants under this submission. All testing conducted met the acceptance criteria and evaluated the worst case scenario including 30° pre-angled abutments as compared to predicate BIOMET 3i designs commercially in the marketplace. Performance testing data indicates that changes to the predicate device are safe and effective for its intended use and it demonstrate to be substantially equivalent. Bench Testing conducted demonstrates that the proposed device meets the mechanical properties recommendations by FDA and ISO Standards.
Two clinical reports on OSSEOTITE® 2 Dental Implants are included with this submission:
- "Insertional Torque Force, Osseotite 2 Placement Data, ● Pressure Necrosis" dated September 21st, 2011. This report provides background information on the thread design for the OSSEOTITE® 2 Dental Implants and a summary of two clinical projects where insertion torque forces are measured. The report includes an analysis of the actual insertion torque forces
3
K111216
for this implant design, the success of the implants at a defined follow-up time point post loading, and a review of the implant failures and their baseline torque values. Additionally, the subject of pressure necrosis that has been alluded with implant placement procedures associated with high insertion torque forces is discussed.
- "BIOMET 3i Insertion Torque Report", dated November 10, . 2011. This report provides an overview of the implant placement experience data for the OSSEOTITE® 2 Dental Implants, including a tabulation of individual insertion torque values and implant failures.
The following FDA Guidance Document for this type of product was Performance Standards: utilized in this submission: "Guidance for Industry and FDA Staff: -Special Controls Class II - Root Form Endosseous Dental Abutment/ Implant". Also, Testing was conducted following ISO standard 14801:2007 Dentistry -- Implants - "Dynamic fatigue test for endosseous dental implants". The test articles met all predetermined acceptance criteria.
The OSSEOTITE® 2 Dental Implants included in this submission have the same intended use, indications for use, technological characteristics, and principles of operation as previously cleared BIOMET 3i OSSEOTITE Certain® Internal and External Connection Implants per the 510(k) numbers referenced in the Predicate Devices section above.
Refer to the following substantial equivalence data table:
| Predicate OSSEOTITE II
MODEL XIFOSSXXX
(Internal Hex)
K100724 | Predicate
OSSEOTITE; OSSEOTITE
NT; XP; TG Implant(s)
(External Hex)
K063286 | Proposed
OSSEOTITE® 2 Dental
Implant(s)
(External Hex)
K111216 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended for surgical placement
in the upper or lower jaw to
provide a means for prosthetic
attachment. | Intended for surgical
placement in the upper or
lower jaw to provide a
means for prosthetic
attachment. | Intended for surgical
placement in the upper
or lower jaw to provide
a means for prosthetic
attachment. |
| Intended for single tooth
restorations and in partially or
fully edentulous spans with
multiple single teeth utilizing
delayed or immediate loading,
or as a terminal or intermediary
abutment for fixed or
removable bridgework, and to
retain overdentures. | Intended for single tooth
restorations and in partially
or fully edentulous spans
with multiple single teeth
utilizing delayed or
immediate loading, or as a
terminal or intermediary
abutment for fixed or
removable bridgework, and
to retain overdentures. | Intended for single
tooth restorations and
in partially or fully
edentulous spans with
multiple single teeth
utilizing delayed or
immediate loading, or
as a terminal or
intermediary abutment
for fixed or removable
bridgework, and to
retain overdentures. |
Substantial Equivalence:
4
KIII 206
| retain overdentures. | |||
|---|---|---|---|
| Provide immediate function | |||
| when good primary stability is | |||
| achieved with appropriate | |||
| occlusal loading to restore | |||
| chewing function. | Provide immediate function | ||
| when good primary | |||
| stability is achieved with | |||
| appropriate occlusal | |||
| loading to restore chewing | |||
| function. | Provide immediate function | ||
| when good primary stability is | |||
| achieved with | |||
| appropriate occlusal | |||
| loading to restore | |||
| chewing function. |
Conclusion:
OSSEOTITE® 2 Dental Implants and predicate designs have the same intended use, indications for use, similar technological characteristics, and principles of operation. The major technological difference between the OSSEOTITE® 2 Dental Implants and its predicates is:
- The ONLY change is the modification of the abutment . connection from an internal feature to an external hex engagement.
The differences noted above do not present new issues of safety or effectiveness for the OSSEOTITE® 2 Dental Implants.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the seal is a stylized symbol that resembles a human figure embracing or supporting three abstract shapes, possibly representing people or services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 .
Ms. Martha I. Garay Senior Regulatory Affairs Specialist BIOMET 3i, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410
NOV 1 8 2011
Re: K111216
Trade/Device Name: OSSEOTTE® 2 - Dental Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: November 10, 2011 Received: November 14, 2011
Dear Ms. Garay:
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. Garay
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 (OS) 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Ph 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
віомет зі Special 510(k) Premarket Notification - OSSEOTITE® 2 Dental Implants
Indications for Use
510(k) Number (if known): K111216
Device Name: OSSEOTITE® 2 –Dental Implants
Indications for Use:
BIOMET 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
OSSEOTITE® 2 Dental Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.
Prescription Use
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
AND/OR
(Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Image /page/7/Picture/13 description: The image shows a document with the title "Concurrence of CDRH, Office of Device Evaluation (ODE)". There is a signature above the text "(Division Sign-Off)". The document also includes the division of Anesthesiology, General Hospital, Infection Control, and Dental Devices. The 510(k) Number is K111216 and the date 4/29 is at the bottom right.