(61 days)
Not Found
No
The summary describes a dental cement and does not mention any AI or ML capabilities.
No.
The intended use describes the product as a dental cement for various applications, which is not typically classified as a therapeutic device. Therapeutic devices are generally those that treat or prevent a disease or condition. This device is primarily for mechanical restoration and bonding.
No
Explanation: The device is described as a "dental cement" with applications like "luting, repair of fractured bridge resins, cementation of adhesive bridge prostheses and CR core posts." These are therapeutic or restorative functions, not diagnostic ones. There is no mention of it being used to identify or analyze a disease or condition.
No
The device description explicitly states the product is a "dental cement," which is a physical material, 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 dental applications like luting, repair, and cementation. This is a direct application within the body (or on a part of the body) for structural purposes, not for testing samples taken from the body to diagnose a condition.
- Device Description: It's described as a dental cement, which is a material used to bond or fill.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or any diagnostic purpose.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This dental cement does not fit that description.
N/A
Intended Use / Indications for Use
For use as a dental cement in various applications, including luting, repair of fractured teeth/bridge resins, cementation of adhesive bridge prostheses and CR core posts.
Product codes
EMA
Device Description
The product is a dental cement which can be either light cured or self cured.
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
dental practitioners
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.
0
JUL 3 1 2001
KO11685
Exhibit D
510(k) Summary
Submitted by:
Daniel J. Manelli Manelli Denison & Selter, P.L.L.C. 2000 M Street, NW (Suite 700) Washington, DC 20036
Telephone: 202-261-1000
On behalf of Tokuyama America, Inc. 510(k) Submission: Bistite II DC May 30, 2001
The product is a dental cement which can be either light cured or self cured. It is
it is a The product is a dental center. Which ban be of carries, luting, repair of fractured intended for use in the cententation of achial as a man as a many of adhesive bridges and CR core posts.
The product is for use only by dental practitioners; it is not intended for OTC use.
The product is for use only be has weed according to directions The product is for use only by dontal practice/
It contains materials that pose no health hazard when used according to directions It contains materials that poss no health miles. It is substantially and has received the approval of the ouplines including the following:
equivalent to various marketed dental cement products, including the following:
| Bistite II SC (Tokuyama) | K991711 |
|---|---|
| Panavia 21 (Kurarey) | K933030 |
| C&B Metabond (Parkhill) | K960464 |
The use of the product is contra-indicated for patients who are hypersensitive to The use of the product is bontra managed to come into contact with skin,
methacrylate monomers. It should not be allowed to chauld be methacitiate monemore. Tt chead. The eyes occur, the eyes should be eyes or clothing. Should bontact with the by immediate contact with a physician.
thoroughly flushed with water followed by immediate contact with a physician.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 31 2001
Tokuyama America, Incorporated C/O Mr. Daniel J. Manelli Attorney Manelli, Denison & Selter, P.L.L.C. riano M Street, NW Suite 700 Washington, D.C. 20036
K011685 Re : Bistite II DC Trade/Device Name: Regulation Number: 872.3275 II Requlatory Class: Product Code: EMA Dated: May 30, 2001 Received: May 31, 2001
Dear Mr. Manelli:
We have reviewed your Section 510(k) notification of intent to
r the back of the freenced showe and we have determined the We have reviewed your seccion from and we have determined the
market the device referenced above and indications for market the device referenced above and a a sudications for
device is substantially equivale maketed predicate device is substancially equilible and the enclosed predicate use stated in the enclosure, co regard market prior to May 28, 2976,
devices marketed in interstate commerce proior to to devices marketed in Interstate commons. Famendments, or to
the enactment date of the Medical in agardance with the the enactment date of the medical bon accordance with the devices that have been recraborrag, and Cosmetic Act (Act).
provisions of the Federal Food, Irvice, subject to the general provisions of the Federal rood, bray, and sect to the general You may, therefore, marries act. The general controls controls provisions of the Act include requirements for annual provisions of the Act Include required manufacturing practice,
registration, listing of devices, good manufacturing and registration, firsting or as as as as a respeared ing and adulteration.
If your device is classified (see above) into either class II
n the may of a classified (seessar Approval), it may If your device Is class III (Passarket Approval), it may
(Special Controls) or class III (Premarket - Exicting major (Special Controls) of Crabb I controls. Existing major be subject to such addicionar controlly. Efound in the Code of Fegulations arrecting your til, Parts 800 to 895.
Federal Regulations, Title 21, Partison accument com ਸ Federal Regulations, firtle 21, facts oversion assumes compliance with substantially equivalence decembered requirements, as set
the Current Good Manufacturing Practice requirements, as set the Current Good Manafacturing - alation (QS) for Medical
forth in the Quality System Regulation (QS) and that forth In the Quarter ByBoom 12) CFR Part 820) and that, Devices: General regarations, the Food and Drug
through periodic QS inspections, the sugh acqumptions through periodic QS inspections, such assumptions. Failure to
Administration (FDA) will verify such assumptions. Failure to Administration (FDA) will version may result in regulatory comply with the GMP regulation may publish further announcements
action. In addition, FDA the Federal Register Please not action. In addition, FBA may publish leaderal Register. Please note:
2
Page 2 - Mr. Manelli
this response to your premarket notification submission does this response to your premaince necessve under sections 531
not affect any obligation you might have under the Flectronic not affect any obligation you might under the Electronic through 542 of the Act IOF devices and on other Federal laws or requlations.
This letter will allow you to begin marketing your device as This letter will allow you conney motification. The FDA described in your 510(x) premarke norrroadevice to a legally
finding of substantial equivalence of your device for vour finding of substantial equivation of yourseification for your marketed predicate device resures in a orabbeared.
device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling If you desire specific acvice tor goal and additionally 809.10 for in
regulation (21 CFR Part 801 and additionally Office of regulation (21 CFR Farc bor anase contact the Office of vitro diagnostic devices), predbe otionally, for questions on
Compliance at (301) 594-4692. Additionally, plaase contact Compliance at (301) 334-5022. Addressederice, please contact
the promotion and advertising of your device, please no the promotion and advertising of your association of the Office of Compliation of Compliation the orrios on entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general premarket notification (zich over the Act may be information on your responsibliation and Manufacturers Assistance
obtained from the Division of Small Manufacturers (201) 443-6597 or obtained from the DIVISION OF Bilair Handadoomaal
at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
it3 Internet addrebb
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy/ Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
3
Exhibit C
Page __ 1__ of __ 1__ 1__
510(k) Number (if known): K011685
Tokuyama Bistite II DC_ Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
For use as a dental cement in various applications, including luting, repair of
es as a dental comed bridge resins, cemtation of adhesive bridge For use as a dental cement in vanous applioutions, moraling and besive bridge prostheses and CR core posts.
(Please Do Not Write Below This Line - Continue On Another Page If Needed)
Concurrence of CDRH, Office of Device evaluation (ODE)
OR
Susan Runn
(Division Sign-Off) (Division Sign-Off)
Division of Dental, Infection Control,
Division of Dental, Infection Devices Division of Dentshital Device 510(k) Number -
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use_