(80 days)
Not Found
Not Found
No
The summary describes a chemical primer for orthodontic adhesives and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is a self-etching primer used with orthodontic adhesives, which is a dental product and not typically classified as a therapeutic device. Its function is to prepare the tooth surface for bonding, not to treat a disease or condition.
No
Explanation: The device is a self-etching primer used for bonding orthodontic adhesives, not for diagnosing medical conditions.
No
The device description clearly states it is a "two bottle, self-etching primer," which is a chemical substance, not software.
No, 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 Description and Intended Use: The description clearly states that this is a "self-etching primer for use with light-curing and self-curing direct bonding orthodontic adhesives." This indicates it's a material used directly on the tooth (enamel) for bonding orthodontic brackets.
- Lack of Biological Sample Testing: There is no mention of testing any biological samples from a patient. The device is applied externally to the tooth surface.
Therefore, based on the provided information, this device falls under the category of a dental material used for bonding, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Intended to be used primarily for etching and priming of enamel for the application of an orthodontic attachment.
A two bottle, self-etching primer for use with light-curing and self-curing direct bonding orthodontic adhesives.
Product codes (comma separated list FDA assigned to the subject device)
DYH
Device Description
A two bottle, self-etching primer for use with light-curing and self-curing direct bonding orthodontic adhesives.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Shear bond strength testing results were reviewed. Based on the resting it Shear bond strength testing rocalle wore rottenes the predicate device and therefore has proven its safety and efficacy.
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.
Transbond™ Plus Self Etching Primer
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
§ 872.3750 Bracket adhesive resin and tooth conditioner.
(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.
0
KO12032 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92
Trade Name: Common Name:
First Step BRACKET ADHESIVE RESIN AND TOOTH CONDITIONER
Classification Name:
BRACKET ADHESIVE RESIN AND TOOTH CONDITIONER 21 CFR 872.3750
Description of Applicant Device:
A two bottle, self-etching primer for use with light-curing and self-curing direct bonding orthodontic adhesives.
Intended Uses of Applicant Device:
Intended to be used primarily for etching and priming of enamel for the application of an orthodontic attachment.
Predicate Device:
Transbond™™ Plus Self Etching Primer
Scientific Concepts and Significant Performance Characteristics:
| | FIRST STEP | Transbond™ Plus
Self Etching Primer |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | A self-etching primer for use with
light-curing and self-curing direct
bonding orthodontic adhesives. | A self etching primer for use only
with light-curing direct bonding
orthodontics adhesives |
| Chemical
Composition | Combination of an acid and
methacrylate. | Combination of an acid and
methacrylate. |
| Mechanical/
Physical
Properties | • Combines etching and priming in
one easy step
• No rinsing
• Etch and primes simultaneously
• Outstanding bond strengths | • Combines etching and priming in
one easy step
• No rinsing
• Etches and primes simultaneously
• Outstanding bond strengths |
1
510(k) Submission for First Step Bisco, Inc., 1100 W. Irving Park Road Schaumburg, IL. 60193
510(k) SUMMARY, continued
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92
Side by side comparisons of First Step to the predicate device Transbond™ Plus Self Side by Side Compansons of Free Stop to the production with the equivalent to the legally marketed device.
Shear bond strength testing results were reviewed. Based on the resting it Shear bond strength testing rocalle wore rottenes the predicate device and therefore has proven its safety and efficacy.
Kathy Joung, Ph.D 1-800-BIS-DENT or 847-534-6106 Fax: 847-891-6865
June 25,2001
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 2001
Ms. Kathy Long Director of Quality Systems Bisco. Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193
Re: K012032
Trade/Device Name: First Step Regulation Number: 872.3750 Regulation Name: Adhesive, Bracket and Tooth Conditioner Accessory Regulatory Class: II Product Code: DYH Dated: June 25, 2001 Received: June 29, 2001
Dear Ms. Long:
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.
3
Page 2 - Ms. Long
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 (section 531-542 of the Act; 21); CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your 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 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 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.
y. Quintero
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Submission for First Step Bisco, Inc., 1100 W. Irving Park Road Schaumburg, IL. 60193
Indications for Use
510(k) Number (if known):
Not Applicable
KO12037
First Step Device Name:
Indications for Use:
A two bottle, self-etching primer for use with light-curing and self-curing direct bonding orthodontic adhesives.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
Prescription Use (Per 21 CFR 801.109) Over-the-Counter Use_
(Optional Format 1-2-96)
Susan Ruano
(Division Sign-Off)
(Division of Dental, (Division Sign-Off)
Division of Dental, Infection Control,
Division of Dental, Infection Devices Division of Dental, finese and Gevicess
and General Hospital Devices and General Hoof 10
000004