(46 days)
Pulpdent Etch-Rite Royale is a 37% phosphoric acid etchant in gel form that is used by the dental professional for etching dentin or enamel before tooth restoration. Etch-Rite Royale is dark blue for contrast with tooth enamel and easy visualization. Etch-Rite Royale is a soft gel that is easily manipulated and that rinses completely without leaving any residue.
Pulpdent Etch-Rite Royale is a 37% phosphoric acid etchant in gel form that is used by the dental professional for etching dentin or enamel before tooth restoration. Etch-Rite Royale is a dark blue color for contrast with tooth enamel and easy visualization. Etch-Rite Royale is a soft gel that is easily applied and manipulated over tooth surfaces, does not run or flow after placement, and rinses completely without leaving any gel residue or color on the tooth.
The provided document is a 510(k) Premarket Notification for a dental product called "Pulpdent Etch-Rite Royale." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific performance acceptance criteria through a study in the same way one might for a novel AI device.
Therefore, many of the requested categories are not applicable to this document as it describes a traditional medical device (etchant gel) and not an AI/ML powered device.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
For this type of device (a phosphoric acid etchant gel), the "acceptance criteria" are primarily related to its chemical composition, physical properties (e.g., consistency, color, rinsability), and its intended use being substantially equivalent to legally marketed predicate devices. The document does not report specific quantitative performance metrics or acceptance criteria in the way an AI device might report sensitivity or specificity.
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|
| Composition (37% phosphoric acid) | 37% phosphoric acid in gel form |
| Form (gel) | Gel form |
| Intended Use (etching dentin/enamel before restoration) | Used for etching dentin or enamel before tooth restoration |
| Color (for contrast and easy visualization) | Dark blue color for contrast and easy visualization |
| Consistency (soft gel, easily applied/manipulated, does not run/flow) | Soft gel that is easily applied and manipulated over tooth surfaces, does not run or flow after placement |
| Rinsability (rinses completely without residue/color) | Rinses completely without leaving any gel residue or color on the tooth |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The document does not describe a clinical or performance study with a test set. This submission relies on demonstrating substantial equivalence to predicate devices, which implies that the safety and effectiveness are established by the long history of safe use of those predicate devices.
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)
- Not Applicable. No test set or ground truth establishment by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication 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
- Not Applicable. This is not an AI-powered device, and no MRMC study is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. As no specific performance study is detailed, no explicit ground truth is mentioned. The safety and effectiveness are inferred from the long-term a "high benefit-to-risk ratio" and "no evidence of short-term or long-term risk or suspicion of any problems" with the predicate devices.
8. The sample size for the training set
- Not Applicable. This is not an AI-powered device requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI-powered device requiring a training set.
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AUG - 5 2003
510 k Premarket Notification Pulpdent Etch-Rite Royale
EXHIBIT 2
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA Telephone: 617-926-6666 617-926-6262 Fax: Email: Pulpdent@pulpdent.com
| DEVICE NAME: | PULPDENT ETCH-RITE ROYALE |
|---|---|
| PREDICATE DEVICES: | Pulpdent Semi-Gel Etchant 35% Phosphoric acid Etchant |
| Pulpdent Etch-Rite 38 % Phosphoric Acid Etching Gel |
DESCRIPTION AND INTENDED USE:
Pulpdent Etch-Rite Royale is a 37% phosphoric acid etchant in gel form that is used by the dental professional for etching dentin or enamel before tooth restoration. Etch-Rite Royale is a dark blue color for contrast with tooth enamel and easy visualization. Etch-Rite Royale is a soft gel that is easily applied and manipulated over tooth surfaces, does not run or flow after placement, and rinses completely without leaving any gel residue or color on the tooth.
COMPARISON WITH PREDICATE PRODUCTS:
Pulpdent Etch-Rite Royale is substantially equivalent in design, composition and intended use to the products listed above. Please see Exhibit 4 for the entire comparison.
SAFETY AND EFFECTIVENESS:
General usage of the predicate products over more than 10 years indicates a high benefit-to-risk ratio. There is no evidence of short-term or long-term risk or suspicion of any problems. In addition, the predicate products listed above have been given 510 (k) Premarket approval as Class II Dental Devices under CFR 872.3690. Please see Exhibit 4 for 510(k) numbers.
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Public Health Service
AUG - 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02472
Re: K031915
Trade/Device Name: Pulpdent Etch-Rite Rovale Regulation Number: 21 CFR 872.3200 Regulation Name: Resin, Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: June 13, 2003 Received: June 24, 2003
Dear Mr. Berk:
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.
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Page 2 - Mr. Kenneth J. Berk
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 (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) you may obtain. 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.
Susan Runnr
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE STATEMENT
11-031915
510 (k) Number (if known)
Device Name Pulpdent Etch-Rite Royale
Indications for Use:
Pulpdent Etch-Rite Royale is a 37% phosphoric acid etchant in gel form that is used by the dental professional for etching dentin or enamel before tooth restoration. Etch-Rite Royale is dark blue for contrast with tooth enamel and easy visualization. Etch-Rite Royale is a soft gel that is easily manipulated and that rinses completely without leaving any residue.
Please do not write below this line. Continue on another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert S. Betz DDS for Dr. K. Mulry
(Division Sign-Off) Division of Anesthesiology, General Hospi Infection Control, Dental De
510(k) Number: K031915
or
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.