(77 days)
Not Found
No
The summary describes root canal posts and their mechanical and biological properties, with no mention of AI or ML.
No
The device, Snowpost & Snowlight posts, is used for structural support in root canals, which is a restorative rather than a therapeutic function. Therapeutic devices typically treat or mitigate a disease or condition, which this device does not.
No.
The device is a root canal post, which is a therapeutic device used to restore a tooth, not a diagnostic device used to identify or determine a disease or condition.
No
The device description is not found, but the performance studies and intended use clearly describe a physical root canal post, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "wherever root canal posts are required," which is a structural and restorative function within the body. IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: While not found, the intended use clearly points to a physical implant.
- Anatomical Site: The device is used within the "root canal," which is part of the patient's anatomy, not a specimen taken from the patient.
- Performance Studies: The performance studies mentioned (cytotoxicity and mechanical tests) are relevant to the biocompatibility and structural integrity of an implantable device, not the analytical performance of a diagnostic test.
The device is a medical device, specifically a dental implant/restorative device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Snowpost & Snowlight composite posts are intended for use by dentists to give retention for reconstruction of non-vital teeth. Snowpost & Snowlight posts are indicated for use wherever root canal posts are required and/or where known metal allergies are of concern.
Product codes
ELR
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canal / non-vital teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists
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)
ISO 10993-5 "Biological evaluation of medical devices - Tests for Cytotoxicity: in vitro methods" was conducted and shows no evidence of a cytotoxic response. Mechanical tests were conducted in conformance with ISO 3597-2-94 Three-point Bending Standard results showed the material to be suitable for root canal posts
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K945370, K000311, K983266, K003221
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3810 Root canal post.
(a)
Identification. A root canal post is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be cemented into the root canal of a tooth to stabilize and support a restoration.(b)
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 the limitations in § 872.9.
0
OCT 1 0 2001
K 012354
510(k) Summary (As Required by 21 C.F.R. §807.92)
| Submitted by: | Craig Bruns
Vice President
Danville Materials, Inc.
2021 Omega Dr.
San Ramon, CA 94583
Phone 925 838-7940
Fax 925 838-0944
e-mail: cbruns@daneng.com | |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Date of summary | July 20, 2001 | |
| Device name | Snowpost & Snowlight | |
| Common name | Glass fiber composite root canal post | |
| Classification names | Regulation Number
972.3810 | Classification Name
Dental root canal post |
| Predicate Device | The modified device is substantially equivalent to the previously cleared Bisco
UM Aesthetic Post (K945370), Coltene ParaPost Fiber White (K000311),
Jeneric/Pentron FibreKor Post (K983266), and Harald Nordin Glassix post
(K003221) devices. | |
| Modifications | The primary differences are minor changes to the material and dimensions. | |
| Intended Use | The modified device has the same intended use as the legally marketed
predicate devices herein referenced. The Snowpost & Snowlight composite
posts are intended for use by dentists to give retention for reconstruction of
non-vital teeth. | |
| Technological
Characteristics | The modified device has the same technological characteristics as the legally
marketed predicate device mechanically supporting reconstruction. | |
| Testing | ISO 10993-5 "Biological evaluation of medical devices - Tests for
Cytotoxicity: in vitro methods" was conducted and shows no evidence of a
cytotoxic response. Mechanical tests were conducted in conformance with ISO
3597-2-94 Three-point Bending Standard results showed the material to be
suitable for root canal posts | |
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 0 2001
Mr. Craig R. Bruns Vice President Danville Materials, Incorporated 2021 Omega Drive San Ramon, California 94583
Re: K012354
Trade/Device Name: Snowpost & Snowlight Regulation Number: 872.3810 Regulation Name: Root Canal Post Regulatory Class: I Product Code: ELR Dated: July 18, 2001 Received: July 25, 2001
Dear Mr. Bruns:
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.
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.
2
Page 2 - Mr. Bruns
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
K. Watoust
Timothy A Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page / of /
K012354 510(k) Number:
Device Name: Snowpost & Snowlight
Indications for use:
Snowpost & Snowlight posts are indicated for use wherever root canal posts are required Showpost & Showingin posts are mellor and/or where known metal allergies are of concern.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off) Division of Dental, Infection Control, and General Hospita 510(k) Number _