(672 days)
Not Found
No
The summary describes a chemical dental cement and does not mention any computational or data-driven components.
No
The device is a dental cement used as an adjunct to secure periodontal dressings, which primarily serves a mechanical purpose rather than directly treating a disease or condition for therapeutic benefit.
No
Oral Bond is described as a liquid dental cement used to secure periodontal dressings. Its function is to assist in a medical procedure (securing dressings), not to identify, monitor, or diagnose a disease or condition.
No
The device description clearly states it is a sterile, liquid dental cement, which 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 is to "temporally assist in securing periodontal dressings." This is a direct application to the patient's oral tissue for a physical purpose (securing a dressing).
- Device Description: The description details a liquid dental cement that polymerizes on contact with water. This is a material used for bonding or sealing, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. Oral Bond is used in vivo (on the body) for a physical function.
N/A
Intended Use / Indications for Use
Oral Bond is indicated to be used as an adjunct to temporally assist in securing periodontal dressings.
Product codes
EMA
Device Description
Oral Bond is a sterile, liquid dental cement containing a monomeric (2-octyl cyanoacrylate) formulation with a viscosity increasing agent, stabilizer, and colorant (D&C Violet #2 or D&C Yellow #10) . Oral Bond is supplied in a multiuse vial. The liquid is syrup-like in viscosity and polymerizes within seconds after contact with water.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral
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
Not Found
Key Metrics
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 6, 2016
Steiner Laboratories Gregory Steiner CEO 1051 Olsen Street, Building 3611 Henderson, Nevada 89011
Re: K142130 Trade/Device Name: Oral Bond Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: May 5, 2016 Received: May 10, 2016
Dear Gregory Steiner:
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. 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 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education 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,
Susan Runno DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K142130
Device Name
Oral Bond
Indications for Use (Describe)
Oral Bond is indicated to be used as an adjunct to temporally assist in securing periodontal dressings.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K142130 510K Summary
SUBMITTED BY
Owner: Gregory Gene Steiner CEO Steiner Biotechnology LLC 1051 Olsen Street, Building 3611 Henderson, Nevada 89011 P 866 317 1348 Contact person: Gregory Gene Steiner (ggsteiner@steinerlabs.com) Date of preparation 06/05/2016
This summary of 510k substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 872.3275. Oral Bond has the same active chemical compound as found in PeriAcryl and is being submitted as a dental cement.
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
| Classification Name: | Dental cement |
|---|---|
| Common/Usual Name: | Dental cement |
| Proprietary Name: | Oral Bond |
| Product Code: | EMA |
| Panel: | Dental |
| Regulation No. | 21 CFR Part 872.3275 |
| Device Class: | Class II |
PREDICATE DEVICE
The predicate device is PeriAcryl.
DEVICE DESCRIPTION
Oral Bond is a sterile, liquid dental cement containing a monomeric (2-octyl cyanoacrylate) formulation with a viscosity increasing agent, stabilizer, and colorant (D&C Violet #2 or D&C Yellow #10) . Oral Bond is supplied in a multiuse vial. The liquid is syrup-like in viscosity and polymerizes within seconds after contact with water.
INDICATIONS FOR USE: Oral Bond is indicated to be used as an adjunct to temporally assist in securing periodontal dressings.
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WARNINGS AND PRECAUTIONS:
Oral Bond is a fast setting adhesive capable of adhering to most bodily tissue and many other materials, such as latex gloves and stainless steel. Inadvertent contact with any body tissue, and any surfaces or equipment that are not disposable or that cannot be readily cleaned with a solvent such as acetone should be avoided.
Polymerization of Oral Bond adhesive may be accelerated by water, saliva or fluids containing alcohol.
It is advised that protective eyewear be provided all patients to prevent Oral Bond coming in contact with the eye. Care must be taken that Oral Bond does not come I contact with the cornea of the eye or into the conjunctival sac where it could cause adhesions. If contact with the eye occurs, flush the eye copiously with saline or water. If residual adhesive remains, apply typical ophthalmic ointment to help loosen the bond and contact and ophthalmologist.
When applying Oral Bond position the patient so any runoff is absorbed by the surrounding cotton gauze. Prevent Oral Bond from flowing past the intended materials that are intended to be bonded.
Once the applicator tip is applied to the syringe express a small amount of Oral Bond outside of the patient's mouth in order to avoid an accidental excessive application of the material in the patient's oral cavity.
If unintended bonding of skin occurs, peel but do not pull the skin apart. Petroleum jelly or acetone may help loosen the bond. Other agents such as water or saline are not expected to immediately loosen the bond.
CONTRAINDICATIONS:
Do not use in patients with a known hypersensitivity to cyanoacrylate or formaldehyde. Oral Bond must not come in contact with the conjunctival sac since conglutination may occur.
Federal law restricts this device for sale on the order of a dentist.
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PREDICATE DEVICE COMPARISON TABLE
| Oral Bond | PeriAcryl | |
|---|---|---|
| 510K | K142130 | K071484 |
| Intended use | Temporary dental adhesive | Temporary dental adhesive |
| Materials | 2-octyl cyanoacrylate | Butyl/octyl |
| cyanoacrylate | ||
| Anatomical site | Oral | Oral |
| Chemical safety | Non-hazardous | Non-hazardous |
| Sterility | Sterile | Not Sterile |
| Biocompatibility | Cytotoxic via ISO agarose overlay | |
| method | Cytotoxic via ISO agarose overlay | |
| method | ||
| Material | ||
| consistency | hard | hard |
| Chemistry of Setting | ||
|---|---|---|
| $A) C≡N n H₂C=C O=C-OR Alkyl 2-Cyanoacrylate OH⁻ → +CH₂-C+ O=C-OR Polycyanoacrylate R = C₈H₁₇$ | $A) C≡N n H₂C=C O=C-OR Alkyl 2-Cyanoacrylate OH⁻ → +CH₂-C+ O=C-OR Polycyanoacrylate R varies (mix of butyl/octyl cyanoacrylate)$ | |
| Working Time | 1 second |