(170 days)
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No
The summary describes a dental sealant material and its physical properties and performance in clinical studies. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
No.
The device is a pit and fissure sealant and orthodontic bracket coating, which are preventive and protective applications, not therapeutic.
No
Explanation: The device is a pit and fissure sealant and orthodontic bracket coating, which are therapeutic and protective functions, not diagnostic. It does not identify or detect a disease or condition.
No
The device is a physical material (sealant) and not a software program. The description focuses on its chemical properties and intended use as a dental material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that Embrace™ WetBond™ Clear Sealant is a material used directly on the patient's teeth and orthodontic brackets. It functions as a sealant and coating, not as a test performed on a sample outside the body.
- Intended Use: The intended use is to seal pits, fissures, and defects, and to coat orthodontic brackets. This is a direct therapeutic or protective application, not a diagnostic one.
Therefore, Embrace™ WetBond™ Clear Sealant is a medical device, but it falls under a different category than in vitro diagnostics.
N/A
Intended Use / Indications for Use
Embrace™ WetBond™ Clear Sealant is a hydrophilic, light-cured material recommended for use as a pit and fissure sealant. Embrace™ WetBond™ Clear Sealant may be used to seal small defects such as buccal pits, lingual grooves or facial surface defects. Embrace™ WetBond™ Clear Sealant may also be used as an orthodontic bracket coating. Embrace™ WetBond™ Clear Sealant hardens/cures such that the material is clear.
Product codes (comma separated list FDA assigned to the subject device)
EBC, EBD
Device Description
Embrace™ WetBond™ Clear Sealant is a hydrophilic, light-cured material recommended for use as a pit and fissure sealant. Embrace™ WetBond™ Clear Sealant may be used small defects such as puch pins, lingual grooves or facial sufface defects. Embrace™ WetBond™ Clear Sealant may also be used as an orthodontic bracket coating. Embrace™ WetBond™ Clear Sealant hardens/cures such that the material is clear.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Four studies, carried out on similar products with the same Embrace™ WetBond™ resin base, demonstrate the effectiveness of Embrace™ WetBond™ materials.
- Penetration depth and marginal leakage of Embrace™ WetBond™ Pit and Fissure Sealant and Small Lesion Restorative Material. Professor Michael DeGrange, Biomaterials Innovations Research Development Laboratory, Paris, France. 2001, 2002.
- Microleakage of surface sealants in Class V restorations after thermal cycling. Pulpdent Corporation.
- In vitro study on toothpaste / toothbrush abrasion resistance of a new dental material: Seal-n-Shine. Pulpdent Corporation.
- Clinical performance of Embrace™ WetBond™ Pit and Fissure Sealant. Dr. JP O'Donnell. 2005.
Laboratory testing has shown that Embrace™ WetBond™ Clear Sealant Is equivalent in physical and mechanical properties to the predicate products. Four years of post-market surveillance of the two Pulpdent predicate has demonstrated only positive feedback from our customers. There have been no serious complaints or failures and no injuries to patients or dental professionals.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 872.3765 Pit and fissure sealant and conditioner.
(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.
0
510 k Premarket Notification K052281 2008 FEB 8 EMBRACE™ WETBOND™ CLEAR SEALANT
EXHIBIT 2 (REVISED)
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA
Telephone: 617-926-6666 Fax: 617-926-6262 Email: ken@pulpdent.com
DEVICE NAME: Embrace™ WetBond™ Clear Sealant
PREDICATE DEVICES:
| Pulpdent Embrace™ Pit and Fissure Sealant | Dentsply Delton Clear |
|---|---|
| Pulpdent Embrace™ Seal-n-Shine | Bisco BisCover |
| Cosmedent CosmeSeal |
DESCRIPTION AND INTENDED USE:
Embrace™ WetBond™ Clear Sealant is a hydrophilic, light-cured material recommended for use as a pit and fissure sealant. Embrace™ WetBond™ Clear Sealant may be used small defects such as puch pins, lingual grooves or facial sufface defects. Embrace™ WetBond™ Clear Sealant may also be used as an orthodontic bracket coating. Embrace™ WetBond™ Clear Sealant hardens/cures such that the material is clear.
COMPARISON WITH PREDICATE PRODUCTS:
Embrace™ WetBond™ Clear Sealant 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:
Pulpdent Embrace™ WetBond™ Clear Sealant is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above. The predicate products have been found substantially equivalent under the 510(k) Premarket Notification process as Class II. Dences under 872.3310 or 872.3765. The chemical in Embrace™ WetBond™ Clear Sealant are the same as those used in the Pulpdent predicate products and equivalent to those used in the other products.
Four studies, carried out on similar products with the same Embrace™ WetBond™ resin base, demonstrate the effectiveness of Embrace™ WetBond™ materials.
- Penetration depth and marginal leakage of Embrace™ WetBond™ Pit and Fissure Sealant and Small Lesion Restorative Material. Professor Michael DeGrange, Biomaterials Innovations Research Development Laboratory, Paris, France. 2001, 2002.
-
- Microleakage of surface sealants in Class V restorations after thermal cycling. Pulpdent Corporation.
-
- In vitro study on toothpaste / toothbrush abrasion resistance of a new dental material: Seal-n-Shine. Pulpdent Corporation.
- · Clinical performance of Embrace™ WetBond™ Pit and Fissure Sealant. Dr. JP O'Donnell. 2005.
There is no ISO or ANSIIADA standard applicable to Embrace™ Clear Sealant. Laboratory testing has shown that Embrace™ WetBond™ Clear Sealant Is equivalent in physical and mechanical properties to the predicate products. Four years of post-market surveillance of the two Pulpdent predicate has demonstrated only positive feedback from our customers. There have been no serious complaints or failures and no injuries to patients or dental professionals. According to the NIH Technology Assessment Conference and Effects and Side-Effects of Dental Restorative Materials: "General usage of these materials over about 20 years indicates a high benefit-to-risk ratio...Both composites and glass ionomers are relatively trouble-fraour is no evidence of short-term or long-term risk...There is no suspicion of any problems after virtually hillions of procedures in the United States."
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 FEB 8
Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02472
Re: K052281
Trade/Device Name: Embrace™ WetBond™ Clear Sealant Regulation Number: 21 CFR 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Code: EBC, EBD Dated: January 31, 2006 Received: February 6, 2006
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. 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 (240) 276-0115. 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 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/industry/support/index.html.
Sincerely yours,
Serita Y. Michael Davis
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K052281
Device Name: Embrace™ WetBond™ Clear Sealant
Indications for Use:
Embrace™ WetBond™ Clear Sealant is a hydrophilic, light-cured material recommended for use as a pit and fissure sealant. Embrace™ WetBond™ Clear Sealant may be used to seal small defects such as buccal pits, lingual grooves or facial surface defects. Embrace™ WetBond™ Clear Sealant may also be used as an orthodontic bracket coating. Embrace™ WetBond™ Clear Sealant hardens/cures such that the material is clear.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sven Russo
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ാ വില്ലിപ്പോൾന്മൃ. General Hospit Joh Control. Dental Devices
K(5522)X