POST CEMENT HI-X

K992248 · Bisco, Inc. · EBF · Aug 25, 1999 · Dental

Device Facts

• Record ID: K992248
• Device Name: POST CEMENT HI-X
• Applicant: Bisco, Inc.
• Product Code: EBF · Dental
• Decision Date: Aug 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

for the cementation of posts . for the cementation of metal posts fabricated with precious, semi-precious or non-precious metals

Device Story

Post Cement Hi-X is a self-cured, radiopaque, resin-based dental cement. It is a two-paste system supplied in syringes, consisting of silica and glass-filled composite. The device is used by dental professionals in a clinical setting for the cementation of fiber and metal posts (precious, semi-precious, or non-precious). It is designed to be used in conjunction with dental adhesive systems (e.g., All-Bond 2 or One-Step Universal Adhesive Systems) to bond micro-mechanically to posts, tooth structure, and silane-treated porcelain. The cement's high opacity in thin layers allows for post visualization on x-ray film. By providing a secure bond for posts, the device aids in the restoration of teeth.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Self-cured, two-paste, resin-based composite dental cement. Contains silica and glass fillers. Radiopaque. Low-viscosity. Supplied in syringes. No specific ASTM standards cited.

Indications for Use

Indicated for the cementation of dental posts, including those fabricated from precious, semi-precious, or non-precious metals.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

• C & B Luting Cement (K940030)

Submission Summary (Full Text)

{0}------------------------------------------------

AUG 25 25 099

### Attachment 5-510(k) Summary

- 1. Bisco, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193 847-534-6000 Contact: Kathryn B. Patterson, Regulatory Affairs Manager Date Prepared: July 2, 1999

| 2. Device Trade Name: | Post Cement Hi-X |
|-----------------------|--------------------|
| Common/Usual Name: | Dental Post Cement |
| Classification Name: | Dental Cement |

- 3. Predicate Device: C & B Luting Cement, K940030 (cleared February 4, 1994)
- 4. Post Cement Hi-X Dental Cement is a self-cured, radiopaque composite and is designed to be used with Bisco's dental adhesive systems such as All-Bond® 2 or One-Step® Universal Adhesive Systems. Post Cement Hi-X will bond micro-mechanically to fiber posts, metal, silane-treated porcelain, fibers and tooth structure. Due to its high opacity in thin layers, Post Cement Hi-X is intended for cementation of posts. When viewed on x-ray film, the outline of any post material with the use of Post Cement Hi-X. Post Cement Hi-X, a low-viscosity, tooth-colored, silica and glass-filled, resin-based composite, is a two-paste, self-cured system. The material is supplied in syringes.
- 5. The intended use of Post Cement Hi-X is:
- for the cementation of posts
- . for the cementation of metal posts fabricated with precious, semi-precious or non-precious metals
- 6. Post Cement Hi-X possesses the same technological characteristics as the predicate device, C & B Luting Cement. Below is a table which shows a side-by-side comparison of the technological characteristics.

| Technological Characteristic | C & B Luting Cement | Post Cement Hi-X |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Intended Use | Cementation of fixed<br>restorations of<br>precious, semi-precious<br>and non-precious<br>metals and of porcelain<br>and composite fixed<br>prostheses. | Cementation of posts<br>and cementation of<br>precious, semi-<br>precious and non-<br>precious metal posts |
| Chemical Composition | Self-cured | Self-cured |
| Physical/Mechanical Properties | High strength, resistant<br>to wear and abrasion | High strength,<br>resistant to wear and<br>abrasion |

{1}------------------------------------------------

| Working Time (room temperature) | 3-4 minutes | 2.5-3.0 minutes |
|---------------------------------|-------------|-----------------|
| Setting Time (room temperature) | 5-7 minutes | 4.5-5.0 minutes |

and the control control consideration of the consideration of the consistential

{2}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a bird in flight, composed of three stylized human profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 25 1999

Ms. Kathryn B. Patterson Requlatory Affairs Manager Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193

K992248 Re : Post Cement Hi-X Trade Name: Regulatory Class: II Product Code: EBF Dated: July 2, 1999 Received: July 6, 1999

Dear Ms. Patterson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{3}------------------------------------------------

## Page 2 - Ms. Patterson

This letter will allow you to begin marketing your device as This lecter will allow your warket notification. The FDA described in your 510 m, promilence of your device to a legally marketed predicate device results in a classification for your marketed predicate device rusules and the to proceed to the market.

If you desire specific advice for your device on our labeling II you desire specific additionally 809.00 for in regulation (21 crk Farc 301 and sease contact the Office of Compliance at [phone]. Additionally, for questions on Compilance at (501) 333 issing of your device, please contact the Office of Compliance at [phone]. Also, please note the office of Companding by reference to the regulation encification" (21 CFR 807.97). Other general premation on your responsibilities under the Act may be Information on your responsible of Small Manufacturers Assistance obtained from the Drvibion on 638-2041 or [phone] or at at its coll-free namber (000) os fea.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Attachment 2 -- Indications for Use

Indications for Use

510(k) Number (if known):__ K 992248 ______________________________________________________________________________________________________________________________________________________________________________

Device Name: Post Cement Hi-X Dental Cement

Indications for Use:

- Cementation of posts 1.
- Cementation of posts fabricated with precious, semi-precious or non-precious metals 2.

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | X OR |
|------------------------------------------|------|
|------------------------------------------|------|

Susan Fraser

| (Division Sign-Off) | |
|------------------------------------------------------------------------|---------|
| Division of Dental, Infection Control,<br>and General Hospital Devices | |
| 510(k) Number | K992241 |

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)