K Number
K013519
Device Name
SIMPLE
Manufacturer
Date Cleared
2002-01-17

(86 days)

Product Code
Regulation Number
872.3200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
1. Direct and Indirect Restorations: to etch enamel/dentin prior to bonding with ONE-Step and some other fifth generation adhesives for use with light-cured composite materials 2. Indirect Restorations: when used with an adhesive, to seal a preparation when using a light-cured composite cement. 3. Densensitization: when used in combination with adhesive, to treat hypersensitive and/or exposed root surfaces.
Device Description
A two bottle (or unit dose container), no rinse self-etching primer for use with light cured dental adhesives.
More Information

Not Found

No
The summary describes a chemical dental product (self-etching primer) and its intended uses, with no mention of software, image processing, AI, ML, or any related concepts.

No.
The device is a self-etching primer used in dental procedures for bonding and desensitization, which are restorative and preventive treatments, not therapeutic in the sense of treating a disease or disorder. Its use involves preparing surfaces for other materials or reducing sensitivity, rather than directly curing a condition.

No

The device description and intended use indicate it is for preparing surfaces for restorations and desensitization, not for diagnosing conditions.

No

The device description clearly states it is a "two bottle (or unit dose container), no rinse self-etching primer," which describes a physical chemical product, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Function: The description clearly states the device is a "self-etching primer for use with light cured dental adhesives." Its intended uses are for preparing tooth surfaces (enamel, dentin, root surfaces) for dental restorations and treating hypersensitivity.
  • Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient to diagnose or detect a condition. It is applied directly to the tooth structure.

Therefore, this device falls under the category of a dental device used for restorative and desensitization procedures, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

  • Direct and Indirect Restorations: to etch enamel/dentin prior to bonding with ONE ● STEP® for use with light-cured composite materials
  • Indirect Restorations: when used with an adhesive, to seal a preparation when using a . light-cured composite cement
  • Desensitization: when used in combination with adhesivo, to treat hypersensitive and/or 8 exposed root surfaces.

Product codes (comma separated list FDA assigned to the subject device)

KLE

Device Description

A two bottle (or unit dose container), no rinse self-etching primer for use with light cured dental adhesives.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

enamel/dentin, root surfaces

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)

Side by side comparisons of SIMPLE to the predicate device Clearfil SE BOND clearly demonstrates that the applicant device is substantially equivalent to the legally marketed devices. The ingredients of Simple were biocompatibility tested, cytotoxicity and acute oral toxicity, and were found to be non-toxic.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K990040

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

The station of the state of the contract and the same of the many of the comments of the comments of

JAN 1 7 2002

Image /page/0/Picture/2 description: The image shows a handwritten string of characters. The string appears to be "KO133519". The characters are written in black ink on a white background. The handwriting is somewhat messy, but the characters are still legible.

Section 5-1

Image /page/0/Picture/4 description: The image shows the logo for BISCO, a company specializing in adhesive and composite technology. The logo consists of a series of interconnected hexagons, each containing a letter that spells out "BISCO". Below the logo, the text "Specialist In Adhesive and Composite Technology" is written in a smaller font. The logo is black and white and appears to be a scan of a printed document.

Bisco, Inc. 1100 W. Irving Park Road Schaumburg, Il 60193 Telephone: (847) 534-6146 Fax: (847) 534-6396 Contact: Stephen D. Smith, Regulatory Affairs Manager

Brenders Science as Virg

SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 190 and 21 CFR par 807.92

Trade Name: Common Name: Classification name:

No Rinse Self-Etching Primer Resin Tooth Bonding Agent Class II per 21 CFR 872.3200

Description of Applicant Device:

A two bottle (or unit dose container), no rinse self-etching primer for use with light cured dental adhesives.

SIMPLE

Intended uses of Applicant Device:

  • Direct and Indirect Restorations: to etch enamel/dentin prior to bonding with ONE ● STEP® for use with light-cured composite materials
  • Indirect Restorations: when used with an adhesive, to seal a preparation when using a . light-cured composite cement
  • Desensitization: when used in combination with adhesivo, to treat hypersensitive and/or 8 exposed root surfaces.

Predicate Devices: Clearfil™ SE BOND K990040 (clearance date of 2/4/99)

Siguificant Performance Characteristics:

SIMPLEClearfil SE BOND
Intended Use:Designed to reduce steps in
preparing dentin and enamel
for composite adhesionDesigned to reduce steps in
preparing dentin and enamel
for composite adhesion
Product
Description:One clear yellow solution
One white slurryTwo clear solutions
Delivery
System:Two solutions in separate
bottles or in a two-chamber
unit dose package.Two solutions in separate
bottles package.

Side by side comparisons of SIMPLE to the predicate device Clearfil SE BOND clearly demonstrates that the applicant device is substantially equivalent to the legally marketed devices. The ingredients of Simple were biocompatibility tested, cytotoxicity and acute oral toxicity, and were found to be non-toxic.

It is concluded that the information supplied in this submission has proven the safety and efficacy of SIMPLE.

Stephen D. Smith Manager of Regulatory Affairs

Tel: 1-800-BISDENT or 847 534-6146 Fax: 847 534-6396

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a wavy line representing the body.

Public Health Service

JAN 1 7 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Stephen D. Smtih Manager of Regulatory Affairs Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193

Re: K013519

Trade/Device Name: Simple Regulation Number: 872.3200 Regulation Name: Resin Dentin Bonding System Regulatory Class: II Product Code: KLE Dated: October 17, 2001 Received: October 23, 2001

Dear Mr. Smith:

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.

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.

2

Page 2 - Mr. Smith

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain_html

Sincerely yours

Timothy A. Ulatowski

Timo Directo Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

3

. Page 1 of Sec. 2

K013519 510(k) Number (if known):

Device Name: SIMPLE

ר

Indications For Use:

  1. Direct and Indirect Restorations: to etch enamel/dentin prior to bonding with ONE-Step and some other fifth generation adhesives for use with light-cured composite materials

  2. Indirect Restorations: when used with an adhesive, to seal a preparation when using a light-cured composite cement.

  3. Densensitization: when used in combination with adhesive, to treat hypersensitive and/or exposed root surfaces.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Susan Riisa

'Division Sign-Off) Division of Dental, Infection Control, ୍ General Hospital D - - General Hospital Devices - 013319