(60 days)
No
The device description focuses on the physical properties and handling of a temporary dental filling material, with no mention of AI or ML.
No.
The device is described as being used for temporary restoration and fillings, which are procedural steps rather than direct treatment of a disease or condition. Its function is to fill cavities temporarily, not to provide therapy or cure.
No
The device is used for temporary restorations and fillings, which are treatment procedures, not diagnostic ones.
No
The device description clearly describes a physical material ("not sticky," "high elasticity," "without any debris in the cavity") used for temporary dental restorations, indicating it is a hardware 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 temporary dental restorations (inlays, onlays, fillings, sealings). This is a direct application within the body (or on a part of the body) for a therapeutic or restorative purpose.
- Device Description: The description focuses on the physical properties and handling of the material for dental procedures.
- 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) 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. This device is used in vivo (within the body) for a restorative dental procedure.
N/A
Intended Use / Indications for Use
- Temporary restoration of inlay and onlay preparations
- Temporary fillings and sealings
Product codes
EBG, EBF
Device Description
used for the temporary restoration of inlay and onlay preparations and all kind of temporary fillings. Spacer™ is easy to handle because it is not sticky. Spacer™ has high elasticity and without any debris in the cavity.
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
Vericom Co. Ltd. র বাংলাদেশের মাধ্যমে আর অনেক সামগ্রীর সম্পাদক মেয়া হয়ে পারে প Healthy and beautiful teeth with Vericom
510(k) Summary
SEP 2 8 2007
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: July 2007
- Company making the submission:
| Submitter | |
|---|---|
| Name | VERICOM Co., Ltd. |
| Address | #606, 5th Dongyoung Venturestel 199-32, Anyang 7-Dong, |
| Manan-Gu, Anyang-Si, Gyeonggi-Do, | |
| Republic of Korea 430-817 | |
| Phone | +82 31 441-2881 |
| Fax | +82 31 441-2883 |
| Contact | Myung-Hwan Oh |
- Device :
Proprietary Name - Spacer™ Common Name - Temporary Filling Materials Classification Name - Material, Tooth Shade, Resin
-
- Predicate Device : Clip, VOCO GMBH, K926418
- Description :
used for the temporary restoration of inlay and onlay preparations and all kind of temporary fillings. Spacer™ is easy to handle because it is not sticky. Spacer™ has high elasticity and without any debris in the cavity.
- Indication for use :
- Temporary restoration of inlay and onlay preparations
- Temporary fillings and sealings
606,5th Dongyoung Venturestel, 199-32, Anyang 7-dong, Manan-gu, Anyang-si, Gyeonggi-do 430-817, Korea
Image /page/0/Picture/19 description: The image shows a logo for a company called "VERICOM" that produces dental materials. The logo is in black and white and features the company name in a stylized font. The words "Dental materials" are printed in a smaller font below the company name. The logo has a curved shape.
013
1
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 depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 8 2007
Dr. Albert Rego Consultant Vericom Company, Limited 27001 La Paz Road, Suite 312 Mission Viejo, California 92691
Re: K072069
Trade/Device Name: Spacer™ Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Codes: EBG, EBF Dated: September 8, 2007 Received: September 18, 2007
Dear Dr. Rego:
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.
2
Page 2- Dr. Rego
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 Part 807); labeling (21 CFR Part 801); 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.
This letter will allow you to begin marketing your device as described in your Section 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). please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known)
Spacer™ Device Name:
Indication for use:
-
Temporary restoration of inlay and onlay preparations
-
Temporary fillings and sealings
Prescription Use
(21CFR801 Subpart D)
OR
Over-The-Counter Use (21CFR801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Gunne
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: ko 72069
Vericom Co., Ltd.
- Indication for use Page # 1 of 1