(90 days)
K0945604, K052591
Not Found
No
The device description and intended use clearly indicate a chemical etching agent, with no mention of software, algorithms, or any technology related to AI/ML.
No
Explanation: The device is described as an etchant for preparing dental surfaces for bonding, primarily for "Etching and cleaning of dentin and enamel" and "Cleaning of restorative surfaces prior to bonding." It does not provide any therapeutic benefit for treating a disease or condition.
No
Explanation: The device is an etchant used for etching and cleaning of dentin and enamel, primarily for bonding procedures. It does not diagnose any condition or disease.
No
The device description clearly states the device is a phosphoric acid semi-gel, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses are for etching and cleaning dental surfaces (dentin and enamel) and cleaning restorative surfaces. These are procedures performed directly on the patient's teeth, not on samples taken from the body for diagnostic purposes.
- Device Description: The description confirms it's a phosphoric acid semi-gel used for preparing tooth surfaces for bonding. This is a therapeutic or procedural application, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
IVDs are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The principle uses of the Bisco Etchants are:
- Etching and cleaning of dentin and enamel 1.
- Cleaning of restorative surfaces prior to bonding 2.
Product codes
KLE
Device Description
The Bisco Etchants are phosphoric acid semi-gels that effectively remove the smear layer, etch and I he insee incenting are produce the necessary microretentive surface for successful bonding.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dentin and enamel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The conclusion of the safety evaluation is that the Bisco Etchants are safe for its intended use.
Side by side comparisons clearly demonstrate that the applicant device is substantialy equivalent to Side by side comparisons Citary demonstrate that the information supplied in this submission has proven the safety and efficacy of this product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Ecliptomer (K0945604), Bisco Etchants (K052591)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for BISCO, a dental company, along with the tagline "Bringing Science to the Art of Dentistry." The image also contains the number K101485 and the date AUG 26 2010. The BISCO logo is made up of three hexagons, each containing two letters.
510 (k) SUMMARY
| Applicant: | Bisco, Inc. |
|---|---|
| 1100 W. Irving Park Road | |
| Schaumburg IL, 60193 | |
| Contact Person: | Michelle Schiltz-Taing |
| Tel: 847-534-6000 | |
| Fax: 847-534-6111 | |
| Date Prepared: | 26 May 2010 |
| Trade Name: | Bisco Etchants |
| Common Name: | Phosphoric Acid Semi-Gel |
| Product Code: | KLE |
| Classification/Name: | Resin Tooth Bonding Agent |
| Class II per 21 CFR 872.3200 |
Description of Applicant Device:
The Bisco Etchants are phosphoric acid semi-gels that effectively remove the smear layer, etch and I he insee incenting are produce the necessary microretentive surface for successful bonding.
Indications for use:
The principle uses of the Bisco Etchants are:
- Etching and cleaning of dentin and enamel 1.
- Cleaning of restorative surfaces prior to bonding 2.
Substantial Equivalence
All components of the Bisco Etchants are found in legally marketed predicate devices. The Bisco All components of the Disco Elections are tound in together technological characteristics as Elections are based upon music cliential vilonis provided in this 510(k) submission that the the Bisco Etchants are substantially equivalent to the predicate devices Ecliptomer (K0945604) and to the Bisco Elchalls are Substant to any equivation to the proded use, indications for use, and chemical that the Disco Officersal Dona - (11525012) in weal properties of the Bisco Etchants demonstrated that the commention of phosphoric acid used is sufficient to clean and to expose dentin tubules, demineralize concentration of phosphoric acultused is sultions to dies demonstrate the ability of Bisco Etchants to clean restorative surfaces.
The conclusion of the safety evaluation is that the Bisco Etchants are safe for its intended use.
Side by side comparisons clearly demonstrate that the applicant device is substantialy equivalent to Side by side comparisons Citary demonstrate that the information supplied in this submission has proven the safety and efficacy of this product.
BISCO, Inc. 1100 W. Irving Park Road Schaumburg, II. 60193 U.S.A.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Michelle Schiltz-Taing Regulatory Affairs Coordinator BISCO, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193
AUG 26 2010
Re: K101485
Trade/Device Name: Bisco Etchants Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE Dated: August 16, 2010 Received: August 18, 2010
Dear Ms. Schiltz-Taing:
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 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.\
2
Page 2 - Ms. Schiltz-Taing
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 vours.
Ph for
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
Enclosure
3
110/485
510 (k) Number (if known):
Device Name: __ Bisco Etchants
Indications for Use:
Bisco Etchants consist of semi-gel phosphoric acids.
The principle uses of the Bisco Etchants are:
-
- Etching and cleaning of dentin and enamel
-
- Cleaning of restorative surfaces prior to bonding
Prescription Use __ (Part 21 CFR 801 Subpart D) AND/OR
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)
A.SBetz DDS for Dr. Susan Runner
nesthestology. General Hospital
510(k) Number: K101485