(64 days)
Not Found
No
The device description and intended use clearly describe a chemical paste for root canal treatment, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is intended to "stimulate the healing process," "promote healing effects," and is described as a "medicament for the treatment" of various dental conditions within root canals. These uses directly address disease or injury.
No
Explanation: The device is described as a root canal filling material and medicament used to stimulate healing, prevent contamination, and promote hard tissue induction and deposition. These are therapeutic functions, not diagnostic ones.
No
The device description clearly states it is a "yellow radiopaque calcium hydroxide paste with iodoform" and is "packaged as a 2 gm syringe" with "enclosed disposable intracanal tips." This describes a physical substance and delivery mechanism, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this device is a "root canal filling material" and is used for "intracanal medicament," "apexification," "temporary root filling," and other procedures directly within the root canal of a tooth. It is applied in vivo (within the body), not in vitro (outside the body).
- Lack of Diagnostic Function: The intended use focuses on stimulating healing, preventing bacterial contamination, and assisting in hard tissue induction and deposition. It does not mention any diagnostic purpose, such as detecting a disease or condition from a sample.
Therefore, this device falls under the category of a medical device used for treatment and filling within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- For use to stimulate the healing process due to the mixture of calcium hydroxide and iodoform and the induction effect of these two ingredients.
- Used to promote healing effects and to help prevent bacterial contamination of the canal, as the two ingredients improve the induction effect for hard tissue induction and deposition.
- To be used as a medicament for the treatment of infected root canals, and as a permanent, low volume additive to the filling process of a treated root canal to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete.
- For use in the treatment of infected root canals, or following pulpectorny, or for the apexedenesis or apexification, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha.
These indications include application in:
- Intracanal Medicament
- Apexification
- Periapical Lesions
- Root Resorption
- Temporary Root Filling
- Perforations
- Underdeveloped pulpless teeth
Product codes (comma separated list FDA assigned to the subject device)
KIF
Device Description
DIAPEX is a yellow radiopaque calcium hydroxide paste with iodoform, used as a root canal filling material. It is packaged as a 2 gm syringe. Intraoral application uses enclosed disposable intracanal tips.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): 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
§ 872.3820 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
ONE DENTIAL
Section 5
JAN 1 6 2004
Pagc 5-1
510 (k) SUMMARY
| 1. Applicant: | Bisco, Inc
1100 West Irving Park Road
Schaumburg, IL 60193 |
|-----------------|------------------------------------------------------------------|
| Contact Person: | Benjamin Lichtenwalner
Ph. 847-534-6146
Fax 847-534-6111 |
| Prepared Date: | November 12, 2003 |
-
- Device Trade Name: DIAPEX Common/Usual Name: Calcium/Iodoform Root Canal Treatment Paste Class II per 21 CFR 872.3820 Rood Canal Filling Resin Classification/Name:
-
- Predicate Device: Vitapex Pre-loaded dental syringe from Neo Dental Chemical Products, cleared under K973667 dated 11/6/1997.
4. Description of Application Device:
DIAPEX is a yellow radiopaque calcium hydroxide paste with iodoform, used as a root canal filling material. It is packaged as a 2 gm syringe. Intraoral application uses enclosed disposable intracanal tips.
5. Intended Uses of Applicant Device:
DIAPEX is used to stimulate the healing process due to the mixture of calcium hydroxide and iodoform and the induction effect of these two ingredients. DIAPEX is used to promote healing effects and to help prevent bacterial contamination of the canal, as the two main ingredicnts improve the induction effect for hard tissue induction and deposition. DIAPEX can also be used as a medicament for the treatment of infected root canals, and as a permanent, low volume additive to the filling process of a treated root canal to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete. The use of DIAPEX in the treatment of infected root canals, or following pulpectomy, or for the apexegenesis or apexification, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha is also indicated.
| Technological
| Characteristic | Vitapex | DIAPEX |
|---|---|---|
| Intended use | Root Canal Filling Material | Root Canal Filling Material |
| Chemical | ||
| composition | Calcium Hydroxide / Iodoform Paste | Calcium Hydroxide / Iodoform Paste |
| Mechanical/ | ||
| Physical properties | Yellow Radiopaque Paste | Yellow Radiopaque Paste |
6. Technological Characteristics:
Side by side comparisons of DIAPEX to the predicate device Vitapex Pre-loaded dental syringe from Neo Dental Chemical Products clearly demonstrates that the applicant device is substantially equivalent to the legally marked device. It is concluded that the information supplied in this submission has proven the safety and efficacy of DIAPEX.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 2004
Mr. Benjamin Lichtenwalner Regulatory Affairs Coordinator Bisco, Incorporated 1100 West Irving Park Road, Schaumburg, Illinois 60193
Rc: K033585
Trade/Device Name: DIAPEX Regulation Number: 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: November 12, 2003 Received: November 13, 2003
Dear Mr. Lichtenwalner:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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. Lichtenwalner
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 Office of Compliance at (301) 594-4613. 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 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 yours.
Ours
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Ko33585
Indications for Use
510(k) Number (if known): K033585
Device Name: DIAPEX
Indications For Use:
- For use to stimulate the healing process due to the mixture of calcium hydroxide and iodoform 1. and the induction effect of these two ingredients.
-
- Used to promote healing effects and to help prevent bacterial contamination of the canal, as the two ingredients improve the induction effect for hard tissue induction and deposition.
- ဒေ To be used as a medicament for the treatment of infected root canals, and as a permanent, low volume additive to the filling process of a treated root canal to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete.
- For use in the treatment of infected root canals, or following pulpectorny, or for the apexedenesis ব or apexification, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha.
These indications include application in:
-
- Intracanal Medicament
- Apexification 2.
- Periapical Lesions నే
- Root Resorption বা
- Temporary Root Filling 5.
-
- Perforations
-
- Underdeveloped pulpless teeth
Prescription Use ✓ AND/OR (Part 21 CFR 801 Subpart D)
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 Burns
Division of Anesthesiology, General Hospital,
510(k) Number: K033353
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