(86 days)
Not Found
No
The summary describes a physical wound dressing and paste, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device functions as a physical barrier to protect injured tissue and avoid further irritation, rather than actively treating a disease or condition. Its purpose is protective, similar to a dressing.
No
Explanation: The device is described as a periodontal wound dressing intended to protect injured tissue and form a temporary physical barrier. Its function is therapeutic (acting as a physical barrier and protecting tissue), not diagnostic (identifying or characterizing a disease or condition).
No
The device description explicitly states that Periogenix consists of disposable dental trays and a canister of topical periodontal paste, which are physical components, not software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of Periogenix is to protect injured periodontal tissue by forming a physical barrier. This is a therapeutic function, not a diagnostic one.
- Device Description: The device consists of trays and a paste that are applied topically to the gums. This is a physical application, not a test performed on a sample taken from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, or tissue) or providing information about a patient's health status based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. Periogenix does not fit this description.
N/A
Intended Use / Indications for Use
Periogenix is a periodontal wound dressing intended to protect injured periodontal tissue (gums) by forming a temporary physical barrier to avoid further irritation.
Product codes
EMA
Device Description
Periogenix consists of thirty (30) disposable, single use dental trays and a canister of topical periodontal paste (TPP). The TPP is dispensed into the single use disposable dental tray, which together provide a moist temporary physical barrier that covers the site of application to avoid further irritation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periodontal tissue (gums)
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)
Biocompatibility, animal, and clinical testing have been performed and have shown that the proposed Periogenix is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
K0835/6
1 of 2
FEB 2009
510(k) Summary for OroScience, Inc Periogenix
1. SUBMITTER/510(K) HOLDER
OroScience, Inc. 2275 East Bayshore Road, Suite 105 Palo Alto, CA 94303 Telephone: 650-856-9600 Facsimile: 650-856-9601 E-mail: prhoule@pacbell.net
Contact Person: Phil Houle Telephone: 650-315-7538
Date Prepared: November 25, 2008
2. DEVICE NAME
Proprietary Name: Periogenix Common/Usual Name: Periodontal dressing Classification Name: Dental Cement
3. PREDICATE DEVICES
- Coe-Pak Periodontal Dressing, Coe Laboratories, Inc. (K881422) .
- Hager Reso-Pac Periodontal Dressing, Hager Worldwide, Inc, (K050658) .
4. DEVICE DESCRIPTION
Periogenix consists of thirty (30) disposable, single use dental trays and a canister of topical periodontal paste (TPP). The TPP is dispensed into the single use disposable dental tray, which together provide a moist temporary physical barrier that covers the site of application to avoid further irritation.
5. INTENDED USE
Periogenix is a periodontal wound dressing intended to protect injured periodontal tissue (gums) by forming a temporary physical barrier to avoid further irritation.
OroScience, Inc., Traditional 510(k) Periogenix
1
K08 3516
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The basic design and application of Periogenix and the predicate devices are similar in that they all provide a temporary physical barrier for oral tissues after oral and periodontal surgery. The formulations of the proposed and predicate devices are different, although the difference in formulation does not affect safety or effectiveness since biocompatibility testing and a clinical evaluation have been performed to support the proposed Periogenix.
Both the proposed Periogenix and the Hager Reso-Pac Periodontal Dressings are similar in that they are neutral in smell and taste, ready-to-use, and provide for a temporary physical barrier. Periogenix TPP is dispensed into a dental tray and placed over the affected area of the dental arch three times daily for up to 10 days. After each treatment, the dental tray is removed and discarded. The Hager Reso-Pac is placed on an applicator and then applied to the affected area. The Reso-Pac stays in place for up to 30 hours and slowly dissolves.
The Coe-Pak Periodontal Dressing is slightly different than Periogenix and Reso-Pac in that the Coe-Pak Dressing is a two-part system consisting of a base and a catalyst that are mixed together chair-side by the dentist. After mixing, the paste is molded into the desired shape and packed over the surgical site on the dental arch after surgery. The paste hardens and the packing is left over the surgical site for up to 10 days until the patient returns to the dentist to have the hardened paste removed. Periogenix uses a premixed biocompatible TPP dispensed from a canister into a dental tray which, when placed over the surgical site of the dental arch, provides a temporary physical barrier. In some cases, the dentist may fabricate a custom dental tray specific to the patient's dental arch. The TPP is then dispensed into the custom dental tray and seated over the affected area of the dental arch three times daily for up to 10 days.
Periogenix and the predicate Coe-Pak and Reso-Pac Periodontal Dressings are all provided non-sterile to the user and are indicated for single use.
7. PERFORMANCE TESTING
Biocompatibility, animal, and clinical testing have been performed and have shown that the proposed Periogenix is safe and effective for its intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three stripes running through the body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.
Public Health Service
FEB 2 0 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OroScience, Incorporated C/0 Ms. Mary McNamara-Cullinane, RAC Senior Regulatory Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
Re: K083516
Trade/Device Name: Periogenix Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: February 12, 2009 Received: February 13, 2009
Dear Ms. McNamara-Cullinane:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 -- Ms. McNamara-Cullinane
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
Suyite J. Michael Davis
Ginette Y. Michaud. M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: Periogenix
Indications for Use:
Periogenix is a periodontal wound dressing intended to protect injured periodontal tissue (gums) by forming a temporary physical barrier to avoid further irritation.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Roreo
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: R083516
OroScience, Inc., Traditional 510(k) Periogenix
November 25, 2008
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