(58 days)
ULTRA DENT OPAL DAM, DEN-MAT PAINT ON RUBBER DAM, PREMIER PERFECTA BLOCK OUT RESIN, SHOFU NIVEOUS LIQUID DAM, LUMA LITE LUMA BLOCK, INTERDENT FAST DAM, BriteSmile BARRIER MATERIAL
Not Found
No
The device description and intended use clearly state it is a light-cured resin acting as a physical barrier. There is no mention of any computational or analytical functions that would involve AI/ML.
No
The device protects soft tissue by creating a physical barrier during dental procedures, which is a protective function, not a therapeutic one. It does not treat or cure any disease or condition.
No
The device, PULPDENT PUTTY DAM, is described as a light-cured resin used to protect soft tissue by creating a physical barrier during dental procedures like bleaching, air abrasion, and etching. Its function is protective, not diagnostic, as it does not gather or analyze data to determine the presence or nature of a disease or condition.
No
The device description clearly states it is a "light-cured resin," which 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 protect soft tissue during dental procedures by creating a physical barrier. This is a direct physical action on the patient's tissue.
- Device Description: The description reinforces the intended use as a physical barrier.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. IVDs are typically used to analyze blood, urine, tissue samples, etc.
This device falls under the category of a dental material used for protection during procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
PULPDENT PUTTY DAM is a light-cured resin used by the dental professional during bleaching, air abrasion and etching procedures. PULPDENT PUTTY DAM protects soft tissue by creating a physical barrier.
Product codes
EIE
Device Description
PULPDENT PUTTY DAM is a light-cured resin used by the dental professional during bleaching, air abrasion and etching procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue (dental)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professional
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)
General usage of these materials over about 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. The safety and effectiveness of these resins is supported by the editors of Reality. 2002.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ULTRA DENT OPAL DAM, DEN-MAT PAINT ON RUBBER DAM, PREMIER PERFECTA BLOCK OUT RESIN, SHOFU NIVEOUS LIQUID DAM, LUMA LITE LUMA BLOCK, INTERDENT FAST DAM, BriteSmile BARRIER MATERIAL
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6300 Rubber dam and accessories.
(a)
Identification. A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in the center intended to isolate a tooth from fluids in the mouth during dental procedures, such as filling a cavity preparation. The device is stretched around a tooth by inserting a tooth through a hole in the center. The device includes the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp. This classification does not include devices intended for use in preventing transmission of sexually transmitted diseases through oral sex; those devices are classified as condoms in § 884.5300 of this chapter.(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 § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.
0
SEP 2 6 2002
510 k Premarket Notification Pulpdent PUTTY DAM
EXHIBIT 2
KQ2522
SUMMARY OF SAFETY AND EFFECTIVENESS DAT
Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA
Telephone: 617-926-6666 Fax: 617-926-6262 Email: Pulpdent@pulpdent.com
DEVICE NAME: PULPDENT PUTTY DAM
PREDICATE DEVICES:
ULTRA DENT OPAL DAM DEN-MAT PAINT ON RUBBER DAM PREMIER PERFECTA BLOCK OUT RESIN SHOFU NIVEOUS LIQUID DAM LUMA LITE LUMA BLOCK INTERDENT FAST DAM BriteSmile BARRIER MATERIAL
DESCRIPTION AND INTENDED USE:
PULPDENT PUTTY DAM is a light-cured resin used by the dental professional during bleaching, air abrasion and etching procedures. PULPDENT PUTTY DAM protects soft tissue by creating a physical barrier.
COMPARISON WITH PREDICATE PRODUCTS:
PULPDENT PUTTY DAM is substantially equivalent in composition and intended use to the products listed above. Please see Exhibit 4 for the entire comparison.
SAFETY AND EFFECTIVENESS:
General usage of these materials over about 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. The safety and effectiveness of these resins is supported by the editors of Reality. 2002. In addition, the predicate products listed above have been given 510 (k) Premarket approval as Class I Dental Devices under CFR 872.4565 and 872.6300. Please see Exhibit 4 for 510(k) numbers.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half. Inside the circle is a stylized image of three human profiles facing right, with flowing lines above and below them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SFP 26 2002
Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street P.O. Box 780 Watertown, Massachusetts 02472
Re: K022522
Trade/Device Name: Pulpdent Putty Dam Regulation Number: 21 CFR 872.6300 Regulation Name: Rubber Dam and Accessories Regulatory Class: I Product Code: EIE Dated: July 25, 2002 Received: July 30, 2002
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.
2
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 accurics. 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
Timothy A. Ulatowski
Timothy A Ulatowski 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
510 (k) Number (if known)
PULPDENT PUTTY DAM Device Name
Indications for Use:
PULPDENT PUTTY DAM is a light-cured resin used by the dental professional during bleaching, air abrasion and etching procedures. PULPDENT PUTTY DAM protects soft tissue by creating a physical barrier.
Please do not write below this line. Continue on another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
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| (Per 21 CFR 801.109) |
or
| (Division Sign-Off) | |
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| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices |
| 510(k) Number: | |
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