(196 days)
Butler® Calci-Flor Prophylaxis Paste is designed to clean and polish teeth during professionally administered dental hygiene prophylaxis treatments.
Butler® Calci-Flor Prophylaxis Paste is intended for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.
Butler® Calci-Flor Prophylaxis Paste is an oral cavity abrasive polishing agent that contains calcium and fluoride. This device is regulated by FDA as a Class I device.
Butler® Calci-Flor Prophylaxis Paste is an abrasive oral prophylaxis paste (available in one of several levels of grit coarseness), which contains fluoride, calcium, humectants, bulking agents for proper paste formation, a sweetener, flavor, color, and preservatives. This device is intended for use by dental professionals, during professionally administered dental prophylaxis treatment (tooth-cleaning), to remove stain from and polish the teeth. Paste application is designed for use with a prophy angle with suitable cup. The device is to be limited to individuals who are professionally trained to perform dental prophylaxis.
The provided document is a 510(k) premarket notification for a dental prophylaxis paste, Butler® Calci-Flor Prophylaxis Paste. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding clinical studies, ground truth, and expert adjudication is not present in this type of submission.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This type of data is not typically presented in a 510(k) submission for a Class I device seeking substantial equivalence based on material composition and intended use. The submission focuses on demonstrating that the new device is "at least as safe and effective as the legally marketed predicate device" through bench testing and comparison of characteristics.
- Acceptance Criteria (Implicit): The implicit acceptance criteria are that the device's characteristics (material composition, intended use, duration of patient contact) are substantially equivalent to predicate devices, and that any new testing (fluoride release) does not raise new questions of safety and effectiveness.
- Reported Device Performance:
- Material Composition: "Butler® Calci-Flor Prophylaxis Paste is made of the same ingredient component materials that are used in lawfully marketed predicate devices..."
- Intended Use/Indications: "...has the same indications for use and intended use as lawfully marketed predicate devices."
- Patient Contact: "...with the same type and durations of patient contact."
- Fluoride Release Data: "Bench testing was performed on the Butler® Calci-Flor Prophylaxis Paste to ascertain fluoride release data." The results "do not raise new questions of safety and effectiveness."
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided because a clinical test set, in the sense of a patient cohort or a large dataset, was not used. The testing described is "bench testing" for fluoride release. Details of this bench testing, including any sample sizes for the laboratory tests, are not elaborated upon in this summary document.
- Data Provenance: Not applicable as no clinical test set was described.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of clinical studies with expert adjudication, is not relevant to this 510(k) submission, which relies on demonstrating substantial equivalence through material comparison and bench testing.
4. Adjudication Method for the Test Set
Not applicable, as no test set requiring clinical adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable, as the device is a prophylaxis paste, not an algorithm or AI system.
7. The Type of Ground Truth Used
The concept of "ground truth" as pathology, outcomes data, or expert consensus is not applicable here. The "truth" in this submission relies on:
- The known characteristics and regulatory history of predicate devices.
- The chemical composition of the new device.
- The results of basic bench testing (fluoride release).
8. The Sample Size for the Training Set
Not applicable. The device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, for the same reason as point 8.
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(02053
FEB - 3 2011
| Date of Summary | 07/16/2010 |
|---|---|
| Submitter/ContactPerson | H. Carl Jenkins |
| The Wood Burditt Group | |
| 10 E. Scranton Ave., Suite 201 | |
| Lake Bluff, IL 60044 | |
| (ph) (847) 234-7500 x 205 | |
| (fax) (847) 574-0728 | |
| (email) hcjenkins@woodburditt.com | |
| Applicant | |
| 4635 W. Foster Ave. | |
| Chicago, IL 60630 | |
| (ph) 773-777-4000 | |
| (fax) 773-777-1417 | |
| Device Name | Butler® Calci-Flor Prophylaxis Paste |
| Common Name | Oral cavity abrasive polishing agent |
| Classification | Oral cavity abrasive polishing agent |
| Regulation Number: 21 CFR 872.6030 | |
| Product Code: EJR | |
| Panel Code: Dental | |
| Device Class: I | |
| Legally MarketedPredicate Devices | BUTLER G.U.M. WITH FLUORIDE |
| JOHN O. BUTLER CO. | |
| K952091 | |
| ProCode: JES | |
| SATIN PROPHYLAXIS PASTE | |
| DENTSPLY INTL. | |
| K912945 | |
| ProCode: EJR | |
| Device Description | |
| PREMIER DENTAL PRODUCTS CO. | |
| K062166 | |
| ProCode: EJR | |
| Butler® Calci-Flor Prophylaxis Paste is an oral cavity abrasivepolishing agent that contains calcium and fluoride. This device is | |
| regulated by FDA as a Class I device. | |
| Butler® Calci-Flor Prophylaxis Paste is an abrasive oral | |
| prophylaxis paste (available in one of several levels of gritcoarseness), which contains fluoride, calcium, humectants, bulkingagents for proper paste formation, a sweetener, flavor, color, andpreservatives. This device is intended for use by dental | |
| professionals, during professionally administered dentalprophylaxis treatment (tooth-cleaning), to remove stain from andpolish the teeth. Paste application is designed for use with aprophy angle with suitable cup. The device is to be limited toindividuals who are professionally trained to perform dentalprophylaxis. | |
| Intended Use andIndications | Butler® Calci-Flor Prophylaxis Paste is designed to clean andpolish teeth during professionally administered dental hygieneprophylaxis treatments. |
| Summary oftechnologicalcharacteristicscompared to predicatedevices | Butler® Calci-Flor Prophylaxis Paste is made of the sameingredient component materials that are used in lawfully marketedpredicate devices, with the same type and durations of patientcontact.Butler® Calci-Flor Prophylaxis Paste has the same indications foruse and intended use as lawfully marketed predicate devices. |
| Performance Testing /Summary ofSubstantialEquivalence (SE) | Bench testing was performed on the Butler® Calci-FlorProphylaxis Paste to ascertain fluoride release data. The results ofthis testing do not raise new questions of safety and effectiveness,and demonstrates that the device is at least as safe and effective asthe legally marketed predicate device. |
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is positioned in the center of a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the border.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Sunstar Americas, Incorporated C/O Mr. Carl Jenkins The Wood Burditt Group 10 E. Scranton Avenue, Suite 201 Lake Bluff, Illinois 60044
FEB - 3 20d
Re: K102053
Trade/Device Name: Butler® Calci-Flor Prophylaxis Paste Regulation Number: 21 CFR 872.6030 Regulation Name: Oral Cavity Abrasive Polishing Agent Regulatory Class: I Product Code: EJR Dated: July 19, 2010 Received: July 22, 2010
Dear Mr. Jenkins:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 899. In addition, FDA may publish further announcements concerning your device in the Federal Register. Comments of the country of the country of the 1
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Page 2- Mr. Jenkins
Enclosure
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Runnes
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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- Indications for Use Statement
Indications for Use
510(k) Number (if known): KJO2053
Device Name: Butler® Calci-Flor Prophylaxis Paste
Indications for Use:
Butler® Calci-Flor Prophylaxis Paste is intended for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner
(Division Sign-Uff) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K102053
- Indications for Use Statement
Page 4.1 of 4.1
§ 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.