(163 days)
Not Found
No
The summary describes a dental liner and base material with chemical and physical properties, and performance testing focuses on material characteristics, not data analysis or algorithmic processing. There is no mention of AI, ML, image processing, or data sets.
No
The device is a dental liner and base material used to prepare cavities before restoration, which is a structural rather than a therapeutic function.
No
The device is described as a "dental liner and base material" used to "line cavity preparations before restoration." Its performance studies focus on material properties like "Flexural strength, Depth of cure, Compressive strength, Radio-opacity, Water sorption, Solubility." These characteristics point to a restorative or protective material, not one used for diagnosis.
No
The device description clearly states it is a light-cured, radiopaque dental liner and base material containing calcium hydroxyl apatite in a urethane dimethacrylate oligomer, indicating it 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 to "line cavity preparations before restoration." This is a direct application within the patient's mouth during a dental procedure.
- Device Description: The description confirms it's a "light-cured Cavity Liner" used with restorative materials.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological or pathological state. It's a material applied directly to the patient's tooth.
Therefore, this device falls under the category of a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Base it is a light-cured, radiopaque dental liner and base material that Contains calcium hydroxyl apatite in a urethane dimethacrylate oligomer. Base it is used to line cavity preparations before restoration.
Product codes (comma separated list FDA assigned to the subject device)
EJK
Device Description
Base it is light-cured Cavity Liner. It is radiopaque cavity liner and base material specially formulated for use with adhesives, composites and conventional restorative materials. It has urethane dimethacrylate base and is similar in chemistry to dental composites.
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)
Testing performed including Flexural strength, Depth of cure, Compressive strength, Radio-opacity, Water sorption, Solubility, Radio-opacity use which demonstrated that the Base it is equivalent to the predicates in specifications and performance characteristics.
Therefore, it was considered that the subject device was as effective as and performs as good as the predicate device.
In conclusion, it can be said that the effectiveness and performance of the subject device are substantially equivalent to those of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3250 Calcium hydroxide cavity liner.
(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the word "SPIDENT" in a stylized, bold font. The letters are black and are enclosed within a black rectangular border. The top and bottom lines of the rectangle are interrupted, creating a unique visual effect.
SPIDENT Co., Ltd.
JUN 1 1 2014
203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdong-Gu, Incheon, Korea 405-821 Tel: +82(32)819-4570 Fax : +82(32)819-4572
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92(c).
Date: November. 22, 2013
- Company and Correspondent making the submission:
| Company | |
|---|---|
| Name | SPIDENT Co., Ltd. |
| Address | 203 & 312, Korea Industrial Complex, 722, |
| Gojan-Dong, Namdong-Gu, Incheon, Korea | |
| 405-821 | |
| Phone | +82(32)819-4570 |
| Fax | +82(32)819-4572 |
| Contact | J. M. Ahn/President |
2. Device:
Proprietary Name - Base it Common Name - Calcium hydroxide cavity liner. Classification Name - liner, cavity, calcium hydroxide
3. Predicate Device:
LIME-LITE, K953079 (LIMELIGHT)
-
- Classifications Names & Citations: EJK, 872.3250
5. Description:
Base it is light-cured Cavity Liner. It is radiopaque cavity liner and base material specially formulated for use with adhesives, composites and conventional restorative materials. It has urethane dimethacrylate base and is similar in chemistry to dental composites.
Base it is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. It is substantially equivalent in design, function and intended use to the predicate devices.
1
Image /page/1/Picture/0 description: The image shows the word "SPIDENT" in bold, sans-serif font. The word is enclosed in a rectangular box, with the top and bottom lines of the box broken at the letter "I". The letters are black, and the background is white.
SPIDENT Co., Ltd.
203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdong-Gu, Incheon, Korea 405-821 Tel: +82(32)819-4570 Fax : +82(32)819-4572
6. Indication for use:
Base it is a light-cured, radiopaque dental liner and base material that Contains calcium hydroxyl apatite in a urethane dimethacrylate oligomer. Base it is used to line cavity preparations before restoration.
7. Performance
Testing performed including Flexural strength, Depth of cure, Compressive strength, Radio-opacity, Water sorption, Solubility, Radio-opacity use which demonstrated that the Base it is equivalent to the predicates in specifications and performance characteristics.
Therefore, it was considered that the subject device was as effective as and performs as good as the predicate device.
In conclusion, it can be said that the effectiveness and performance of the subject device are substantially equivalent to those of the predicate device.
8. Biocompatibility
Biocompatibility testing confirmed that the device meets the applicable requirements of the FDA Blue Book Memorandum #95-1 entitled Use of International Standards ISO 10993 Biological Evaluation of Medical Devices Part -1: Evaluation and Testing, and is biocompatible. Accordingly, it was considered that the subject device was p substantially equivalent in safety to the predicate device.
| No. | Testing Biocompatibility | Results |
|---|---|---|
| 1 | Cytotoxicity | Pass |
| 2 | Sensitization | Pass |
| 3 | Irritation or Intracutaneous reactivity | Pass |
| 4 | Subacute toxicity | Pass |
| 5 | Genotoxocity | Pass |
9. Review:
The Base it has the similar device characteristics as the predicate device, the LIME-LITE; intended use, material, chemical composition, design and use concept are similar.
The Base it has the similar mechanical properties as the predicate device: Flexural Strength. Depth of cure, Compressive Strength, and Solubility,
The Base it has been subjected to extensive safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the US regulations and ISO 9917-2.
2
Image /page/2/Picture/0 description: The image shows a logo with the word "SPIDENT" in a stylized font. The letters "SPI" are enclosed in a square box with rounded corners, while the letters "DENT" are placed to the right of the box, with the top line of the box extending over the letters "DE". The overall design is simple and modern, with a focus on the company name.
SPIDENT Co., Ltd.
203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdong-Gu, Incheon, Korea 405-821 Tel: +82(32)819-4570 Fax : +82(32)819-4572
Based on the comparison of intended use and technical features, the Base it is substantially equivalent to the predicate devices.
-
- Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, FDA's "Guidance for the Preparation of Premarket notifications for Dental Composite" and based on the information provided in this premarket notification SPIDENT Co., Ltd. concludes that the Base it is safe and effective and substantially equivalent to predicate devices as described herein.
- Conclusions:
-
- SPIDENT Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA.
END
- SPIDENT Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with flowing lines, representing movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem. The logo is simple, using a single color, and is designed to be easily recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 11, 2014
SPIDENT Company, Limited C/O Ms. Lena Pak SPIDENT USA, Incorporated 2115 Linwood Avenue 50 Floor, Suite 521 Fort Lee, NJ 07024
Re: K134022
Trade/Device Name: Base It Regulation Number: 21 CFR 872.3250 Regulation Name: Calcium Hydroxide Cavity Liner Regulatory Class: II Product Code: EJK Dated: March 5, 2014 Received: March 14, 2014
Dear Ms. Pak:
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.
:
. .
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Page 2 - Ms. Pak
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); 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" (21CFR 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,
Mary S. Runner -S . . . . . . . . . . . . . . . . . .
Erin I. Keith. M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number K __ K134022
Device Name: Base it
Indication for use:
Base it is a light-cured, radiopaque dental liner and base material that Contains calcium bydroxyl apatite in a urethane dimethacrylate oligomer. Base it is used to line cavity preparations before restoration.
.
Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21CFR801 Subpart D)
AND/OR Over-The-Counter Use _ (Per 21CFR807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
:
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sheena A. Green -S 2014.06.11 11:21:30 -04'00'
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