DIAPEX

K033585 · Bisco, Inc. · KIF · Jan 16, 2004 · Dental

Device Facts

• Record ID: K033585
• Device Name: DIAPEX
• Applicant: Bisco, Inc.
• Product Code: KIF · Dental
• Decision Date: Jan 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

DIAPEX is a yellow radiopaque calcium hydroxide and iodoform paste used as a root canal filling material. Supplied in a 2 gm syringe with disposable intracanal tips for intraoral application by dental professionals. Functions as a medicament to prevent bacterial contamination and stimulate hard tissue induction/deposition during root canal procedures. Applied during final filling with gutta-percha or as a temporary filling/medicament. Benefits include accelerated healing and improved outcomes for infected canals, apexification, and root resorption cases.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and chemical composition comparison to predicate device.

Technological Characteristics

Radiopaque paste containing calcium hydroxide and iodoform. Delivered via 2 gm syringe with disposable intracanal tips. Class II device (21 CFR 872.3820).

Indications for Use

Indicated for patients requiring root canal therapy, including treatment of infected root canals, pulpectomy, apexogenesis, apexification, and tip filling of prepared canals. Applications include intracanal medicament, periapical lesions, root resorption, temporary root filling, perforations, and underdeveloped pulpless teeth.

Regulatory Classification

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.

Predicate Devices

• Vitapex Pre-loaded dental syringe (K973667)

Submission Summary (Full Text)

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# ONE DENTIAL

# Section 5

JAN 1 6 2004

Pagc 5-1

# 510 (k) SUMMARY

| 1. Applicant: | Bisco, Inc<br>1100 West Irving Park Road<br>Schaumburg, IL 60193 |
|-----------------|------------------------------------------------------------------|
| Contact Person: | Benjamin Lichtenwalner<br>Ph. 847-534-6146<br>Fax [phone] |
| Prepared Date: | November 12, 2003 |

- 2. 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:
- 3. 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<br>Characteristic | Vitapex | DIAPEX |
|------------------------------------|------------------------------------|------------------------------------|
| Intended use | Root Canal Filling Material | Root Canal Filling Material |
| Chemical<br>composition | Calcium Hydroxide / Iodoform Paste | Calcium Hydroxide / Iodoform Paste |
| Mechanical/<br>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.

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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.

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### 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 [phone]. 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 [phone] or [phone] 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

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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.
- 2. 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:

- 1. Intracanal Medicament
- Apexification 2.
- Periapical Lesions నే
- Root Resorption বা
- Temporary Root Filling 5.
- 6. Perforations
- 7. 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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