(67 days)
Not Found
No
The summary describes a material composition for root canal filling and does not mention any computational or analytical functions that would typically involve AI/ML.
No
GuttaFlow is a material used for permanent obturation (filling) of root canals, not a device that applies therapy through interaction or energy delivery.
No
Explanation: The device is described as a "material for permanent obturation of root canals" and a "permanent root canal filling material," indicating it is used for treatment rather than diagnosis.
No
The device description clearly states that GuttaFlow is a material composed of various physical substances (silicone, gutta percha, zinc oxide, etc.), indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "permanent obturation of root canals," which is a procedure performed in vivo (within the body) to fill a physical space.
- Device Description: The device is described as a "permanent root canal filling material," which is a substance used to physically fill a space within the body.
- 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 screening.
IVDs are typically used to analyze biological samples outside of the body to gain diagnostic information. GuttaFlow is a material used inside the body for a therapeutic purpose (filling a root canal).
N/A
Intended Use / Indications for Use
GuttaFlow is a material for permanent obturation of root canals after vital extirpation and after treatment of pulpal gangrene and temporary filling of the canal.
Product codes
KIF and EKM
Device Description
GuttaFlow is a Class II, permanent root canal filling material. GuttaFlow is silicone based (Polydimethysiloxane) and consists additionally of Gutta Percha, Zinc oxide, Zircondioxide, paraffin-based oil, silicone oil, hexachloroplatinic acid, and silicic acid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canals
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)
Not Found
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
§ 872.3820 Root canal filling resin.
(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
OV = 3 2003
coltène
whaledent
510(k) Submission GuttaFlow 510 (K) STATEMENT ( Summary ) (As required by 21 CFR 807.93)
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21CFR § 807.92.
-
- GuttaFlow is a Class II, permanent root canal filling material.
-
- GuttaFlow is substantially equivalent to RoekoSeal-K973539 which is also manufactured and distributed by Coltène/Whaledent.GmbH + Co. KG.
-
- GuttaFlow is silicone based (Polydimethysiloxane) and consists additionally of Gutta Percha, Zinc oxide, Zircondioxide, paraffin-based oil, silicone oil, hexachloroplatinic acid, and silicic acid.
-
- The technical characteristics of Gutta Flow are similar to those of the predicate device RoekoSeal which is also silicone based. Dimension stability, flow, film thickness, biocompatibility and solubility are very similar for both materials. Differences are primarily in the GuttaFlow curing time and the addition of Gutta Percha and Zinc oxide.
-
- GuttaFlow and RoekoSeal are not resorbable.
(Signature)
H. Vogelstein
N/A
Date 20 August 2013
Official Correspondent &
US @gent
(Premarket Notification [510(k)]Number)
380-12
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes above its head, symbolizing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Public Health Service
NOV - 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Coltene/Whaledent GmbH & Company KG C/O Mr. Henry J. Vogelstein Consultant Coltene/Whaledent, Incorporated 235 Ascot Parkway Cuyahoga Falls, Ohio 44223
Re: K032662
Trade/Device Name: GuttaFlow Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Codes: KIF and EKM Dated: August 22, 2003 Received: August 28, 2003
Dear Mr. Vogelstein:
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.
2
Page 2 -- Mr. Henry J. Vogelstein
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 (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.
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 Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Patricia Cucenttfor
Chiu S. Lin. PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Page 1 of
14032662 510(k) Number (if known):
Device Name: GuttaFlow
Indications for Use:
GuttaFlow is a material for permanent obturation of root canals after vital extirpation and after treatment of pulpal gangrene and temporary filling of the canal.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use V (Per 21 CFR 801.109)
OR Over-the-Counter Use
Suser Runo
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K033662