(196 days)
No
The device is a prophylaxis paste, a physical substance used for cleaning and polishing teeth, and its mechanism of action is chemical (occluding dentinal tubules). There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is used for cleaning and polishing teeth and for immediate relief of tooth sensitivity, which are not considered therapeutic uses.
No
The device is a prophylaxis paste used for cleaning, polishing, and reducing tooth sensitivity, which are therapeutic and cosmetic functions, not diagnostic ones.
No
The device is a prophylaxis paste, which is a physical substance applied to teeth, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for cleaning and polishing teeth during a dental prophylaxis and for relieving tooth sensitivity. This is a direct treatment applied to the patient's oral cavity.
- Device Description: The description reinforces the use as a paste applied during a dental procedure to clean and polish and to reduce sensitivity by occluding dentinal tubules.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVDs are used to perform tests on samples taken from the body to provide diagnostic information. This device is a therapeutic and prophylactic agent applied directly to the patient.
N/A
Intended Use / Indications for Use
Butler GUM® Prophylaxis 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.
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.
Product codes
EJR
Device Description
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 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.
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
professionally administered
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6030 Oral cavity abrasive polishing agent.
(a)
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).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
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Image /page/0/Picture/1 description: The image shows a logo with the text "U Biomaterials" underneath a graphic. The graphic appears to be a cluster of small circles and irregular shapes. The text is in a simple, sans-serif font and is left-aligned with the graphic above it.
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: 386.418.1551 Fax: 386.418.1465 Email: greenspan@usbiomat.com 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
1
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.
2
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
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.
3
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 (240) 276-0115. 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 (240) 276-3150 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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Image /page/4/Picture/3 description: The image shows a logo with a stylized mountain or triangular shape at the top. Below the shape, there is text that reads "UCSBmaterials". The text is in a smaller font size compared to the graphic above it.
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: 386.418.1551 Fax: 386.418.1465
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| 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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