(75 days)
OCTYLDENT® Dental Adhesive
Not Found
No
The description focuses on the chemical composition and polymerization process of the adhesive, with no mention of AI or ML.
No.
The device is described as an adhesive for bonding dental caps and crowns to teeth, functioning as a dental cement. Its primary purpose is structural adhesion, not to treat or prevent a disease or condition.
No
The device is described as an adhesive for bonding caps and crowns to teeth, and its function involves polymerization to form a strong adhesive bond. Diagnostic devices are used to identify or detect medical conditions, diseases, or abnormalities, which is not the stated purpose or function of this dental adhesive.
No
The device description clearly states it is a liquid adhesive formula packaged in a physical ampoule with an applicator tip, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for bonding caps and crowns to teeth. This is a direct application to the body for a structural purpose, not for examining specimens from the body to provide diagnostic information.
- Device Description: The description details a liquid adhesive that polymerizes to form a bond. This is a physical process for adhesion, not a chemical or biological reaction used for diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting analytes, or providing diagnostic results.
- Performance Studies: The performance studies focus on chemical, physical, and biocompatibility testing to demonstrate equivalence as a dental cement, not on diagnostic accuracy or performance metrics like sensitivity or specificity.
IVD devices are used to examine specimens (like blood, urine, tissue) 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
LiquiBand® Dental n-butyl cyanoacrylate is intended for use as a permanent cementation when bonding of crown and caps to teeth is desired.
Product codes
EMA
Device Description
The LiquiBand® Dental adhesive formula consists of n-butyl cyanoacrylate monomer containing small amounts of hydroquinone (a free radical inhibitor) and sulfur dioxide (an anionic inhibitor).
LiquiBand® Dental, n-butyl cyanoacrylate adhesive, is a clear, colorless, free-flowing liquid packaged in a single use, 0.5 gram high density polyethylene ampoule with an attachable polypropylene applicator tip. It is applied as a liquid monomer to the bonding surface of the cap/crown to be cemented to a tooth. Upon seating the cap/crown and contact with weak bases LiguiBand® Dental polymerizes as to form a strong adhesive bond between the cap/crown and tooth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
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
Nonclinical testing: LiquiBand Dental adhesive was subjected to chemical, physical and biocompatibility testing to demonstrate its equivalence to OCTYLDENT® Dental Adhesive. All of the testing supported the substantial equivalence by the similarity of the test results. Both products are effective as dental cements. Based on this data, it was concluded that LiquiBand® Dental adhesive is substantially equivalent to OCTYLDENT® Dental Adhesive.
Key Metrics
Not Found
Predicate Device(s)
OCTYLDENT® Dental Adhesive
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
Image /page/0/Picture/1 description: The image shows a sequence of characters, specifically 'K93556'. The characters are written in a bold, rounded font, giving them a distinct and somewhat playful appearance. The black color of the characters contrasts sharply with the white background, making them easily readable. The characters are arranged horizontally, with each character clearly separated from the others.
JAN - 3 2000
510(k) Summary
Submitter
MedLogic Global Corporation 4815 List Drive, Suite 111 Colorado Springs, Colorado 80919
Contact:
Stephen J. Tamsett Manager Regulatory Affairs and Quality Assurance
Phone: 1-800-625-6442 Fax: 1-719-535-2930
Date summary was prepared:
October 19, 1999
Name(s) of the device
LiquiBand® Dental adhesive
Identification of predicate device(s)
The predicate device for LiquiBand® Dental adhesive is OCTYLDENT® Dental Adhesive by Closure Medical Corporation
Description of the device
The LiquiBand® Dental adhesive formula consists of n-butyl cyanoacrylate monomer containing small amounts of hydroquinone (a free radical inhibitor) and sulfur dioxide (an anionic inhibitor).
LiquiBand® Dental, n-butyl cyanoacrylate adhesive, is a clear, colorless, free-flowing liquid packaged in a single use, 0.5 gram high density polyethylene ampoule with an attachable polypropylene applicator tip. It is applied as a liquid monomer to the bonding surface of the cap/crown to be cemented to a tooth. Upon seating the cap/crown and contact with weak bases LiguiBand® Dental polymerizes as to form a strong adhesive bond between the cap/crown and tooth.
Intended Use
LiquiBand® Dental n-butyl cyanoacrylate is intended for use as a permanent cementation when bonding of crown and caps to teeth is desired.
Comparison of device characteristics to predicate
LiquiBand® Dental adhesive is substantially equivalent to OCTYLDENT® Dental Adhesive. This is based on the same intended use, similar materials and similar means of application.
1
510(k) Notification
Nonclinical testing
LiquiBand Dental adhesive was subjected to chemical, physical and biocompatibility testing to demonstrate its equivalence to OCTYLDENT® Dental Adhesive. All of the testing supported the substantial equivalence by the similarity of the test results. Both products are effective as dental cements. Based on this data, it was concluded that LiquiBand® Dental adhesive is substantially equivalent to OCTYLDENT® Dental Adhesive.
Conclusion
Based on the descriptive information and the performance data provided in this premarket notification, it is concluded that the LiquiBand® Dental adhesive is substantially equivalent to OCTYLDENT® Dental Adhesive by Closure Medical Corporation, a legally marketed dental adhesive.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a symbol consisting of three stylized human figures or profiles, arranged in a way that they appear to be interconnected or overlapping.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 3 2000
Dr. Walter Fabisiak, Director Product Development and Regulatory Affairs and Quality Assurance MedLoqic Global Corporation 4815 List Drive Colorado Springs, Colorado 80919
K993556 Re :
Liquiband® Dental Trade Name: Requlatory Class: II Product Code: EMA December 14, 1999 Dated: Received: December 15, 1999
Dear Mr. Fabisiak:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
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Page 2 - Mr. Fabisiak
the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.ffa.gov/cdrh/dsmamain.html".
Sincerely yours,
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
Indications for Use: LiquiBand® Dental Adhesive
LiquiBand® Dental n-butyl cyanoacrylate is intended for use as an adhesive when bonding of caps and crowns to teeth is desired.
Prescription Use
(Per 21 CFR 801.109)
Susan Russo
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _
00021
MEDLOGIC GLOBAL CORPORATION - LiquiBand® Dental adhesive