(64 days)
Not Found
No
The description focuses on the chemical and physical properties of a dental resin cement and does not mention any computational or analytical capabilities that would suggest AI/ML.
No
The device is a dental resin cement used for bonding dental prosthetics; it does not perform any therapeutic function.
No
The device is described as a "Dental Resin Cement" used for "cementation," indicating its function is for bonding dental restorations, not for diagnosing medical conditions.
No
The device description clearly states it is a "universal, dual-cured resin 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 the "cementation of porcelain and composite inlays, onlays, crowns and veneers" and "conventional cementation of metallic inlays, onlays, crowns and fixed partial dentures." This describes a material used in the body for structural purposes in dental procedures.
- Device Description: The description confirms it's a "universal, dual-cured resin cement." This is a material used directly on or in the patient's mouth.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, while this device is a material used in the body for restorative purposes.
N/A
Intended Use / Indications for Use
ILLUSION, a universal, dual-cured resin cement, is based on an opacity/translucency (value) system, and is intended for the cementation of porcelain and composite inlays, onlays, crowns and veneers. ILLUSION can also be used for conventional cementation of metallic inlays, onlays, crowns and fixed partial dentures.
Intended Use of ILLUSION: dental resin cement
Product codes
EMA
Device Description
ILLUSION, a universal, dual-cured resin cement, is based on an opacity/translucency (value) system.
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
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
K 993192
510(k) Summary ILLUSIONTM
- 1: Bisco, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193 847-534-6000 Contact: Kathryn B. Patterson, Regulatory Affairs Manager Date Propared: September 14, 1999
-
- · Device Trade Name: ILLUSION Common/Usual Name: Dental Resin Cement Classification Name: Dental Cement [21 CFR 872.3275]
- Choice™, K875313 (cleared March 10, 1988) ന് Predicate Device:
- ILLUSION, a universal, dual-cured resin cement, is based on an opacity/translucency (value) 4. system, and is intended for the cementation of porcelain and composite inlays, onlays, crowns and veneers. ILLUSION can also be used for conventional cementation of metallic inlays, onlavs, crowns and fixed partial dentures.
- ડ, Intended Use of ILLUSION:
- . dental resin cement
- II.LUSION possesses the same tcchnological characteristics as the predicate device, Choice. ਦੋ Below is a table which shows a side-by-side comparison of the technological characteristics.
| Technological Characteristic | Choice | ILLUSION |
|---|---|---|
| Intended Use | Cement | Cement |
| Chemical Composition | Dual-cured | Dual-cured |
| Physical/Mechanical Properties: | ||
| Diametrical Tensile Strength (L/C*) | 49 MPa (8) | 43 MPa (8) |
| Diametrical Tensile Strength | ||
| (C/C**) | 38 MPa (8) | 41 MPa (8) |
| Compressive Strength (L/C) | 198 MPa (6) | 260 MPa (6) |
| Compressive Strength (C/C) | N/A | 231 MPa (6) |
| Barcol Hardness (L/C 20 sec., 2 mm | ||
| thickness) | 79/60 (3) | 82/59 (3) |
| Modulus (L/C) | 8.7 GPa (5) | 5.6 GPa (5) |
| Working Time (Min:Sec) | 5:00/10:00 | 4:30/9:30 |
*Light-cured
**Chemical-cured
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 27 1999
Ms. Kathryn B. Patterson Regulatory Affairs Manager Bisco, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193
K993192 Re :
Illusion Trade Name: Regulatory Class: II Product Code: EMA Dated: August 23, 1999 Dated. August 24, 1999
Dear Ms. Patterson:
We have reviewed your Section 510 (k) notification of intent to
r the may be have founded above and we have determined the We have reviewed your section 310(x) hours betermined the
market the device referenced above and we have indications for market the device referenced above and wo market ons for
device is substantially equivalent (for the indications for device is substantially equivalent (ior encreated in interstate
use stated in the enclosure) to devices marketed in interstate
n the enclosed in the May 28, 1976 the enactme use stated in the enciosure) co de readstment date of the commerce prior to May 26, 1978, che sices that have been
Medical Device Amendments, or to devices that have of the F Medical Device Amendents, of Co devices cias now of the Federal reclassified in accordance with the provinay, therefore, Food, Drug, and Cosmeric Acc (noc). Provisions provisions
market the device, subject to the general controls of the Act evice, subject co the gonvisions of the Act of the Act. of the Act. The general concrols pistration, listing of
include requirements for annual regist go, labeling, and include requirements For annuralice, labeling, and devices, good manufacturing ping and adulteration.
If your device is classified (see above) into either class II
n the see and the cases of a TIT (Promaxker, Approval), it may If your device 15 class III (Premarket Approval), it may
(Special Controls) or class III (Premarket Approval), Evisting major (Special Controls) of Crass Irr (Special - Existing major
be subject to such additional controls. Existing major be subject to such addressional our device can be found in the Code of regulations arrecting your at Parts 800 to 895. A Eederal Regulations, firtle zi, rares essumes compliance with
substantially equivalent determination nevices: General substantially equivalent deteimination icalina.
the Good Manufacturing Practice for Medical Devices: chrough periodic the Good Manufacturing Practice 201 and that through periodic
(GMP) regulation (21 CFR Part Rout Rough Stration (FDA) will (GMP) regulation (2) Crk Farc over administration (PDA) will GMP inspections, the rood and been and with the GMP verify such assumptions. Farlatory action. In addition, FDA regulation may resure in regarats concerning your device in
may publish further announcements concerning your and may publish further announcements contrise of this response to your the Federal Register. Freasons in affect any
2
Paye 2 - Ms. Patterson
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions ander the Biections Product Radiations.
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) , and additionally 809.10 for
Compliance at (201) 50 1500 150 Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-1639. Also, please note the regulation entifica, "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.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
#hy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Attachment 2 - Indications for Use
Indications for Use
510(k) Number (if known): K875313
Device Name: ILLUSION™
Indications for Use:
Dental Resin Cement 1.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use X (Per 21 CFR 801.109)
us-567 -4. V. Da
(Division Sign-Off) Division of Dental, Infection Control, Invision of Dental, Infection Gontrollorio 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
000002