BUTLER GUM PROPHY PASTE WITH NOVAMIN

K024343 · Usbiomaterials Corp. · EJR · Jul 11, 2003 · Dental

Device Facts

• Record ID: K024343
• Device Name: BUTLER GUM PROPHY PASTE WITH NOVAMIN
• Applicant: Usbiomaterials Corp.
• Product Code: EJR · Dental
• Decision Date: Jul 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6030
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Bulter GUM® Prophylaxsis Paste with NovaMin® is intended for use in a professionally administered cleaning and polishing procedure during the prophylaxis treatment. The NovaMin® in the paste reduces sensitivity by occluding dentinal tubules.

Device Story

Butler GUM Prophylaxis Paste with NovaMin is a dental abrasive polishing agent. It contains NovaMin (sodium-calcium-phosphosilicate) particles. Applied by dental professionals during routine prophylaxis, scaling, or root planing procedures. The paste functions by physically occluding exposed dentinal tubules, thereby reducing tooth sensitivity. It is used in a clinical dental setting by practitioners. The device provides both mechanical cleaning/polishing and therapeutic desensitization benefits to the patient.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and material safety profile.

Technological Characteristics

Oral cavity abrasive polishing agent containing NovaMin (sodium-calcium-phosphosilicate) as the active ingredient for dentinal tubule occlusion. Class I device.

Indications for Use

Indicated for cleaning and polishing during professional dental prophylaxis treatment and for immediate relief of tooth sensitivity post-scaling and root planing.

Regulatory Classification

Identification

An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).

Predicate Devices

• ProClude® (K002989)

Submission Summary (Full Text)

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# JUL 1 1 2003

SIOMATERIALS CORPORATION 09 PROGRESS BLVD., #23 CHUA. FL 32615

#### 9.0 510(K) SUMMARY

# 9.1 Submitter's Name and Contact Information

David C. Greenspan, Ph.D., Vice President & Chief Technology Contact Person: Officer Phone: [phone] Fax: [phone] Email: [e-mail] USBiomaterials Corporation Submitter Company: 13709 Progress Blvd, #23 Alachua, FL 32615 December 23, 2002 Date Prepared

#### 9.2 Name of Device and Name/Address of Applicant

Butler GUM® Prophylaxis Paste with NovaMin®

USBiomaterials Corporation 13709 Progress Blvd., #23 Alachua, Florida 32615

#### 9.3 Name and Address of Manufacturer

Germiphene Corporation P.O. Box 1748 Brantford ON Canada N3T 5V7 1379 Colborne St., E. Brantford ON Canada N3T 5M1

### 9.4 Common or Usual Name

Prophylaxis Paste

### 9.5 Classification Name

872.6030 Oral cavity abrasive polishing agent

#### 9.6 Predicate Device

ProClude® K002989

#### 9.7 Intended Use

Bulter GUM® Prophylaxsis Paste with NovaMin® is intended for use in a professionally administered cleaning and polishing procedure during the prophylaxis treatment. The NovaMin® in the paste reduces sensitivity by occluding dentinal tubules.

# 9.8 Technological Characteristics and Substantial Equivalence

All of the components found in Bulter GUM® Prophylaxis Paste with NovaMin® have been used in the predicate device, or have been found to be safe for dental use. NovaMin® is a sodium-calcium-phosphosilicate particulate that has been shown to

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USBIOMATERIALS CORPORATION
13709 PROGRESS BLVD., #23 ALACHUA, FL 32615 USA

physically occlude dentinal tubules in the same manner as the calcium carbonate/arginine complex in the predicate device, ProClude® (K002989). Studies have concluded that NovaMin® is a non-irritant, and non-sensitizer, and is non-toxic.

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# MAY 1 3 2DD8

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

David C. Greenspan, Ph. D. Vice President, Chief Technology Officer US Biomaterials Corporation 13709 Progress Boulevard, Suite 23 Alachua, Florida 32615

Re: K024343

Trade/Device Name: Butler Gum Prophylaxis Paste with NovaMin® Regulation Number: 21 CFR 872.6030 Regulation Name: Oral Cavity Abrasive Polishing Agent Regulatory Class: I Product Code: EJR Dated: April 23, 2008 Received: May 24, 2008

Dear Dr. Greenspan:

This letter corrects our substantially equivalent letter of July 11, 2003.

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.

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Page 2 - Dr. Greenspan

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/industry/support/index.html.

Sincerely yours,

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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USBIOMATERIALS CORPORATION 13709 PROGRISS BLVD., #23 ALACHUA, FL 32615 USA

#### 1.0 STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): K024343

USBiomaterials Corporation Applicant: 13709 Progress Blvd., #23 Alachua, FL 32615 Phone: [phone] Fax: [phone]

Device Name: Prophylaxis Paste with Bioactive Glass

Proprietary Name: Butler GUM® Prophylaxis Paste with NovaMin®

#### Indications For Use:

Butler GUM Prophylaxis Paste with NovaMin® is intended for cleaning and polishing procedures as a part of a professionally administered dental prophylaxis treatment. Secondarily, Butler GUM® Prophylaxis Paste with NovaMin® can be used for the immediate relief of tooth sensitivity, post-scaling and root planing.

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| | Ho Maly Sa MS |
|---------------------------------------------------------------------------------|----------------------|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| 510(k) Number: | K024343 |
| Prescription Use | |
| (Optional Format 1-2-96) | |
| OR | Over-The-Counter Use |

Concurrence of CDRH, Office of Device Evaluation (ODE)

USBiomaterials Corporation

CONFIDENTIAL

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