(302 days)
No
The device description and performance studies focus on the chemical and physical properties of a dental adhesive, with no mention of AI or ML technologies.
No
The device is an adhesive used for bonding dental restorations and desensitizing teeth, which are structural and protective functions, not therapeutic.
No
The device is an adhesive used for various dental restorations and procedures, not for diagnosing conditions.
No
The device description clearly indicates it is a chemical adhesive product used in dental procedures, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to dental procedures performed directly on the tooth (bonding restorations, desensitization, repair). These are clinical procedures, not laboratory tests performed on samples taken from the body.
- Device Description: The description details a dental adhesive used for bonding materials to teeth. It describes its chemical properties and how it functions in a clinical setting.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
All-Bond Universal SC adhesive is used for:
- Direct Restorations (e.g. resin-based composite, resin-modified glass ionomer, core . build-ups)
- Indirect Restorations (e.g. metal, glass, ceramics, zirconia/alumina) ◆
- Bonding Resin or Primer for Substrates .
- Desensitization/Sealing of Tooth .
- Intraoral Repair (e.g. chipped porcelain, additions to direct restorations)
Product codes
KLE
Device Description
All-Bond Universal SC is an auto-polymerizing adhesive with a light-curing alternative. It is designed for the dentist who prefers not to light cure the adhesive layer under indirect restorations. All-Bond Universal SC has a low film thickness (
§ 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 word "BISCO" in bold, sans-serif font. Above the word is a geometric design consisting of several interconnected, three-dimensional shapes that resemble stylized honeycombs or crystals. The overall impression is that of a logo or brand mark, possibly for a company or product named BISCO.
510 (k) SUMMARY
Applicant:
Bisco, Inc. 1100 W. Irving Park Road Schaumburg IL, 60193
Contact Person:
Michelle Schiltz-Taing Tel: 847-534-6146 Fax: 847-534-6146
Date Prepared:
26 August 2013
Trade Name: Common Name: Product Code: Classification/Name:
All-Bond Universal SC Self and Light Curable Dental Adhesive KLE Resin Tooth Bonding Agent Class II per 21 CFR 872.3200
Predicate Devices:
All-Bond Universal SC is substantially equivalent to:
ACE Bond SE by Bisco, Inc. Schaumburg IL K063780
Indications for Use:
All-Bond Universal SC adhesive is used for:
- Direct Restorations (e.g. resin-based composite, resin-modified glass ionomer, core . build-ups)
- Indirect Restorations (e.g. metal, glass, ceramics, zirconia/alumina) ◆
- Bonding Resin or Primer for Substrates .
- Desensitization/Sealing of Tooth .
- Intraoral Repair (e.g. chipped porcelain, additions to direct restorations)
BISCO, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193 U.S.A. 800-247-3368 or 847-534-6000 Fax: 847-891-5049 www.bisco.com
K13773
1
Image /page/1/Picture/0 description: The image shows the logo for BISCO. The logo consists of a series of interconnected, three-dimensional hexagonal shapes arranged in a row above the word "BISCO". The hexagonal shapes are shaded to give them a three-dimensional appearance. The word "BISCO" is written in a bold, sans-serif font.
510 (k) SUMMARY (continued)
Description of Applicant Device:
All-Bond Universal SC is an auto-polymerizing adhesive with a light-curing alternative. It is designed for the dentist who prefers not to light cure the adhesive layer under indirect restorations. All-Bond Universal SC has a low film thickness (40% by weight) | X | X |
| Self-Etching Dental Adhesive | X | X |
| Total-Etching Dental Adhesive | X | X |
BISCO, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193 U.S.A. 800-247-3368 or 847-534-6000 Fax: 847-891-5049 www.bisco.com
11
An ISO: 13485 Certified Company.
2
Image /page/2/Picture/0 description: The image shows the word "BISCO" in large, bold letters. Above the word, there is a geometric design composed of several interconnected, three-dimensional shapes. The shapes appear to be arranged in a row, creating a visually interesting pattern above the text.
510 (k) SUMMARY (continued)
Biocompatibility:
An evaluation of biocompatibility was conducted using ISO 7405:2008 to determine the safety of All-Bond Universal SC. It is concluded from the safety evaluation and the results of the Oral Toxicity Study (10 rats, 14 days) that All-Bond Universal SC was not toxic in this test."
Conclusion:
Side by side comparisons clearly demonstrate that the applicant device is substantially equivalent to the other legally marketed devices. It is concluded that the information supplied in this submission has demonstrated that All-Bond Universal SC is substantially equivalent to the legally marketed predicate device.
BİSCO, İnc. 1100 W. Irving Park Road Schaumburg, IL:60193 U.S.A.
800-247-3368 or 847-534-6000 Fax: 847-891-5049 www.bisco.com
An ISO 13485 Certified Company
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle.
ood and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
April 11, 2014
Bisco, Incorporated Ms. Michelle Schiltz-Taing 1100 W. Irving Park Road Schaumburg, IL 60193
Re: K131734
Trade/Device Name: All-Bond Universal SC Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: March 3, 2014 Received: March 12, 2014
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 for about 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 may of subjoct to additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K131734 510 (k) Number (if known):
Device Name: _ All-Bond Universal SC .........................................................................................................................................
Indications for Use:
All-Bond Universal SC adhesive is used for:
- Direct Restorations (e.g. resin-based composite, resin-modified glass ionomer, . core build-ups)
- Indirect Restorations (e.g. metal, glass, ceramics, zirconia/alumina) .
- Bonding Resin or Primer for Substrates ●
- Desensitization/Sealing of Tooth �
- Intraoral Repair (e.g. chipped porcelain, additions to direct restorations) �
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
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)