(64 days)
Not Found
No
The summary describes a chemical adhesive and does not mention any computational or data-driven components.
No.
The device is used for bonding dental materials and temporary attachment, not for treating diseases or conditions.
No
The device is indicated for use as dental cement for bonding dental materials or temporarily attaching a fiber to the tooth, which are functional applications rather than diagnostic ones.
No
The device description clearly states it is a liquid monomer packaged in glass vials, indicating it is a physical substance and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of GluSite is as a dental cement for bonding dental materials and temporarily attaching fibers to teeth. This is a direct application to the body for a structural or therapeutic purpose.
- Device Description: The description details a liquid monomer that polymerizes upon contact with weak bases to form an adhesive bond. This describes a material used for bonding within the oral cavity.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., outside of the body to gain diagnostic information. GluSite's function is entirely within the body for a non-diagnostic purpose.
N/A
Intended Use / Indications for Use
GluSite is indicated for use as dental cement for bonding dental materials such as crowns, caps, and pins, or temporarily attaching a fiber to the surface of the tooth in a procedure to treat periodontal disease.
Product codes
EMA
Device Description
GluSite (2-octyl cynoacrylate) is a clear colorless, free-flowing liquid monomer packaged in a glass multiple-use vials. Upon contact with weak bases, GluSite polymerizes to form a strong adhesive bond. Depending on the availability of moisture, this could take up to one minute.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
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 § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
K 013446.
510(k) SUMMARY
The Summary of Safety and Effectiveness on the GlaSite reflects data available and experiences in the time the submission was The Summary of Saley and Elfectivelies on the Glickle reliects data Prairies and or test may requires in the closes of the conclusions or recommendations set forth.
| Applicant | Don Blacklock
GluStitch, Inc.
7188 Progress Way, #307
Delta, BC., V4G 1M6 | DEC 2 0 2001 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Telephone | (800) 667-2130 | |
| Facsimile | (877) 450-4000 | |
| Date | October 15, 2001 | |
| Name | GluSite | |
| Classification | Dental Cement, 21 CFR 872.3275 | |
| Predicate: | CLOSURE Medical Corporation's Octyldent®, K980159 – market
clearance date, April 9, 1998 | |
| Description | GluSite (2-octyl cynoacrylate) is a clear colorless, free-flowing liquid
monomer packaged in a glass multiple-use vials. Upon contact with weak
bases, GluSite polymerizes to form a strong adhesive bond. Depending on
the availability of moisture, this could take up to one minute. | |
| Intended Use | GluSite is indicated for use as dental cement for bonding dental materials
such as crowns, caps, and pins, or temporarily attaching a fiber to the
surface of the tooth in a procedure to treat periodontal disease. | |
| Contraindication: | • GluSite is contraindicated for use in patients with hypersensitivity to
the adhesive.
• GluSite must not come in contact with the conjunctival sac since
conglutination may occur. | |
| Caution: | • Federal law (U.S.A.) restricts this device to sale by or on the order of a
physician. | |
| Technological
Characteristics | The intended use of the GluStitch, Inc.'s GluSite and CLOSURE Medical
Corporation's Octyldent® are equivalent. The chemical composition,
octyl cyanoacrylate are equivalent, and test results demonstrates that the
two devices are equivalent in performance. | |
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2001
Mr. Donald Blacklock President GluStitch, Incorporated #307 7188 Process Way Delta, British Columbia, CANADA
Re: K013446
Trade/Device Name: GluSite Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: October 15, 2001 Received: October 15, 2001
Dear Mr. Blacklock:
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
2
Page 2 - Mr. Blacklock
of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I oderal buter and systements, including, but not limited to: registration You must comply with an the Free Progant CPT CFR Part 801); good manufacturing practice allu listing (21 OF R Pat 007), acclines (QS) regulation (21 CFR Part 820); and if requirences as set form in the qualify is a 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 I his letter will anow you to ocgin maneting your and equivalence of your device to 310(k) promance noticate 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 If you desire specific ac not 70. Jour for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and Office of Collightance at (e office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under nother (11 OF CF CF CF CF CF CF Cr of Small Manufacturers, International and the Act may of obtained install-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
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| 510(k) Number (if known): | K013446 |
|---|---|
| Device Name: | GluSite |
Indications For Use:
GluSite is indicated for use as dental cement for bonding dental materials such as
the tooth Grusite is indicated for as as demail concerners a fiber to the surface of the tooth in a procedure to treat periodontal disease.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off)
510(k) Number _
and General Hospital Dev
user Ninger
Division Sign-only
Division of Dental, Infection Control,
OR
Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________
1 / 008
(Optional Format 1-2-96)