(58 days)
Pulpdent Cavity Preparation IV is used by the dental professional as one step in the preparation of teeth for veneers, inlays, crowns, onlays, amalgam and composite resin restorations. Pulpdent Cavity Preparation IV, an aqueous solution of chlorhexidine gluconate, cleans and moistens tooth structure to facilitate bonding with adhesives that require moist surfaces. It can also be used prior to sealing dentin tubules. Recent studies have suggested that this "cleansing" step reduces micro leakage and sensitivity in teeth undergoing treatment or restorations. Pulpdent makes no claim as to the antimicrobial effect of chlorhexidine gluconate.
Pulpdent Cavity Preparation IV, an aqueous solution of chlorhexidine gluconate, cleans and moistens tooth structure to facilitate bonding with adhesives that require moist surfaces.
The provided documents are a 510(k) premarket notification for "PULPDENT Cavity Preparation IV." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data that would typically include detailed acceptance criteria and performance studies.
Therefore, the information required in your request regarding acceptance criteria, sample sizes, expert qualifications, and study methodologies is not present in the provided text. The submission focuses on comparing the new device's composition and intended use to existing predicate devices to establish safety and effectiveness based on that comparison.
Here's a breakdown of what is in the document related to your request, and what is conspicuously absent:
1. A table of acceptance criteria and the reported device performance
- Absent. The document does not define specific acceptance criteria for performance metrics (e.g., bonding strength, antimicrobial efficacy, or clinical outcomes), nor does it report direct performance data for the device against such criteria. The "Safety and Effectiveness" section merely states that the materials are "accepted by the Council on Dental Therapeutics and have been used safely in dental procedures for decades." This refers to the general safety of the components, not the performance of the final device against defined criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Absent. No clinical or laboratory test sets are described. The submission relies on substantial equivalence to predicate devices, not new performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Absent. There is no mention of expert involvement in establishing ground truth for any test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Absent. No test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Absent. This device is a dental preparation solution, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI-related metrics are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Absent. Not applicable to this type of device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Absent. No ground truth establishment is described as there are no new performance studies. The "ground truth" for this submission is based on the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
- Absent. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Absent. No training set or associated ground truth establishment is mentioned.
In summary: The provided document is a regulatory submission demonstrating substantial equivalence for a dental preparation solution. It does not contain the type of detailed performance study data, acceptance criteria, sample sizes, or expert involvement typically associated with clinical trials or AI/diagnostic device validation. The "study" here is implicitly a "comparison with predicate products" as mentioned in "Exhibit 5" (which is not provided in full but referenced).
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PULPDENT CORPORATION
510 k Premarket Notification Pulpdent Cavity Preparation IV
EXHIBIT 4
RESPONSE TO SMDA OF 1990
DEC 1 2 2001
9
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA
617-926-6666 Telephone: 617-926-6262 Fax:
DEVICE NAME:
PULPDENT Cavity Preparation IV
PREDICATE DEVICES:
Pulpdent Cavity Preparation II Ultradent: Consepsis BISCO Cavity Cleanser
DESCRIPTION AND INTENDED USE:
Pulpdent Cavity Preparation IV is used by the dental professional as one step in the Pulpdent Cavity Preparation IV is used by the dental process.
preparation of teeth for veneers, inlays, crowns, onlays, amalgam and composite resin restorations.
restorations.
Pulpdent Cavity Preparation IV, an aqueous solution of chlorhexidire majot surfaces Pulpdent Cavity Preparation TV, "an aquodo ovith adhesives that require moist surfaces.
and moistens tooth structure to facilitate bonding with adhesives that this and molstens toom structure to laumate of laings. Recent studies have suggested this this It can also be used prior to sealing dontin tubers. Treeth undergoing treatment of cleansing step Teddes Thilor loakers sentimicrobial effect of chlorhexidine gluconate.
COMPARISON WITH PREDICATE PRODUCTS:
Pulpdent Cavity Preparations are substantially equivalent in composition and intended Pulpdent Cavity Preparations are Gabotantian) Squrantialy Squarantire comparison.
use to the predicate products listed above. Please see Exhibit 5 for the entire compariso
SAFETY AND EFFECTIVENESS:
The materials that make up these products are accepted by the Council on Dental The materials that make up those products for decades. In addition, the Therapedits and have been used ballery in dones proval as Class II Dental Devices under CFR 872.3260.
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, in the center. Encircling the caduceus are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The seal is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 2 2001
Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street P. O. Box 780 Watertown, Massachusetts 02471-0780
Re: K013411
Trade/Device Name: Pulpdent Cavity Preparation Regulation Number: 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: October 9, 2001 Received: October 15, 20001
Dear Mr. Berk:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Section 970(2) proceed.
referenced above and have determined the device is substantially equivalent (for the referenced above and have decembered to legally marketed predicate devices marketed in indications for use stated in the ensiesary to enginent date of the Medical Device interstate collinetee prior to may 20, 1978, as a secondance with the provisions of Amendments, or to de vices that nave oose (Act) that do not require approval of a premarket the Federal Food, Drug, and Cosmene 110 (110) ................................................................................................................................ apploval application (1 Nirry) - 1 The general controls provisions of the Act include controls provisions of the Fict - First Jisting of devices, good manufacturing practice, requirements for aid prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III II your device is classinod (500 a0010) in the subject to such and the major regulations affecting (FMA), it may of subject to sach adding the end Regulations, Title 21, Parts 800 to 898. In your device can be found in the South nouncements 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
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Page 2 - Mr. Berk
of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally receitar statutes and regulations, but not limited to: registration
You must comply with all the Act's requirements, including, but not limited to pressio You must comply with an this Free Free Free 21 CFR Part 801); good manufacturing practice and if in the (21 CFR I att 607), laceling (21 CFR Pat 820); and if requirents as set form in the quality of exceller (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 This letter will anow you to begin manoching your substantial equivalence of your device to 510(K) premarket nourceation. 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 II you desire specific advice for your for in vitro diagnostic devices), please contact the and additionally 21 CFR Part 609-4613. Additionally, for questions on the promotion and Office of Comphance at (301) 594-4639 contact the Office of Compliance at (301) 594-4639. advertising or your a ...
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under noutication (ZTCI K Part 007.97). Oaks golds Manufacturers, International and the Act may be obtained from the Brumber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
[Signature]
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE STATEMENT
KU13411
510 (k) Number (if known)
PULPDENT CAVITY PREPARATION IV Device Name
Indications for Use:
Pulpdent Cavity Preparation IV is used by the dental professional as one step in the I updelly of teeth for veneers, inlays, crowns, onlays, amalgam and composite resin restorations.
Pulpdent Cavity Preparation IV, an aqueous solution of chlorhexidine gluconate, cleans and moistens tooth structure to facilitate bonding with adhesives that require moist surfaces. These molsteris toom Straotars to taoling dentin tubules. Recent studies have suggested that products our alle be acouces micro leakage sensitivity in teeth undergoing treatment or this "olounting" otop" (ourses no claim as to the antimicrobial effect of chlorhexidine gluconate.
Please do not write below this line. Continue on another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use or Prescription Use V (Per 21 CFR 801.109) Division Sign-Off) ്രാമ of Dental, Infection Control, r Tieneral Hospital De id imber _____________________________________________________________________________________________________________________________________________________________________
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.