(50 days)
BLO2X Oxygen Blocker is intended to prevent negative contour in areas where oxygen inhibition of resin polymerization results in premature material loss. Use it before curing composites or luting to prevent the oxygen inhibition layer from forming. BLO2X Oxygen Blocker allows removal of luting resins closer to the final contour before curing, thus eliminating the need to address a large excess of cured composite or luting cement.
BLO2X Oxygen Blocker is a clear, glycerin-based gel containing a viscosity-inducing agent, producing a gel with similar viscosity characteristics to the predicate product.
The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria for the BLO₂X Oxygen Blocker.
The document is a 510(k) summary for a dental device, "BLO₂X Oxygen Blocker," which describes its intended use, technological characteristics, and comparison to a predicate device (DeOx®) to demonstrate substantial equivalence. It does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes, data provenance, number or qualifications of experts, or adjudication methods for a test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
- The type of ground truth used, or sample size and ground truth establishment for a training set.
The document focuses on establishing substantial equivalence to a legally marketed predicate device based on intended use and technological characteristics, rather than presenting a performance study with specific acceptance criteria.
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OCT 2 2 2010
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PO Box 1478 Bellevue, Washington USA 98009-1478
2929 NE Northun Way Phone: (425) 827 4694 Bellevue, Washington Toll Free: 1 800 USA 98004
Fax: (425) 827,6893
510(k) SUMMARY (AS REQUIRED BY SECTION 807.92c)
Submitted/Prepared by: Vincent M. Tentarelli Pascal Company, Inc. 2929 NE Northup Way Bellevue, WA 98004 USA
Quality Assurance Manager Title:
- Contact Information: Voice: (425) 602.3633 Fax: (425) 827.6893 Email: vmtentarelli@pascaldental.com
- Date Prepared: October 19, 2010
Manufacturer/Applicant: Pascal Co., Inc.
2929 NE Northup Way Site Address: Bellevue, WA 98004
- Mailing Address: PO Box 1478 Bellevue, WA 98009-1478
Est. Reg. No .: 3011632
Trade Name: BLO2X Oxygen Blocker
Common Name Tooth Shade Resin
Material, Tooth Shade, Resin Classification Name:
Device Class: Class II
Device Panel: Dental
Regulation Number: 21 CFR 872.3690
Product Code: EBF
BLO₂X Oxygen Blocker: 510(k) Summary Revision 1.2 Page 1 of 3
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| Substantial equivalence: | BLO₂X Oxygen Blocker is substantially equivalent to the originally classified device described in CFR 872.3690 "Material, Tooth Shade, Resin." It is also substantially equivalent and nearly identical to (for example ) the following product that is currently on the market, having been cleared by 510(k): |
|---|---|
| Predicate Product | |
| Trade Name: | DeOx®, Oxygen Barrier Viscous Solution |
| 510(k) Number: | K941065 |
| Owner: | Ultradent Products, Inc. |
| Address: | 505 W. 10200 So. |
South Jordan, UT 84095
Substantial Equivalence/Comparison to Predicate
The document, "Guidance on the CDRH Premarket Notification Review Program, June 30, 1986 (K86-3)" was used to determine substantial equivalence.
| Intended Use |
|---|
| BLOOD Oxygen Blend |
| BLO₂X Oxygen Blocker: | BLO₂X Oxygen Blocker has the same intended use, “to prevent negative contour in areas where oxygen inhibition of resin polymerization results in premature material loss,” as cleared by the 510(k) process, as listed above. |
|---|---|
| ----------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
- Use DeOx® to prevent negative contour in areas where oxygen DeOx®: inhibition of resin polymerization results in premature material loss.
Use it before curing composites or luting to prevent the oxygen inhibition layer from forming. DeOx® allows removal of luting resins closer to the final contour before curing, thus eliminating the need to address a large excess of cured composite or luting cement.
Technological Characteristics
The technological characteristics for this product are the same as BLO2X Oxygen Blocker: those for the predicate device and other products currently on the market except for minor variations in the same or similar components.
BLO2X Oxygen Blocker is a clear, glycerin-based gel containing a viscosity-inducing agent, producing a gel with similar viscosity characteristics to the predicate product.
- According to product literature and the MSDA, the predicate product, DeOx®: DeOx® is a glycerin-based viscous solution.
BLO₂X Oxygen Blocker: 510(k) Summary Revision 1.2 Page 2 of 3
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Descriptive Information BLO2X Oxygen Blocker:
Descriptive information provided shows that the materials from which Pascal Co., Inc.'s BLO2X Oxygen Blocker is made are substantially equivalent to (nearly identical with some) those of similar products, used for identical purposes, currently on the market.
Comparison to Predicate Product Description BLO2X Oxygen Blocker:
BLO2X Oxygen Blocker is a clear, viscous, glycerin-based gel designed to prevent oxygen inhibition layer formation on the surface of resin materials when they are polymerized.
The use of BLO2X Oxygen Blocker during the application of the last composite layer is to prevent the oxygen from inhibiting the material's ability to reach final polymerization. The presence of oxygen during this final phase increases the risk of the loss of the final layer of composite material. This may result in a premature material loss of the applied composite material.
DeOx®:
DeOx® is a clear, viscous, glycerin-based solution designed to prevent oxygen inhibition layer formation on the surface of resin materials when they are polymerized.
Indications for Use BLO2X Oxygen Blocker:
BLO2X Oxygen Blocker is intended to prevent negative contour in areas where oxygen inhibition of resin polymerization results in premature material loss. Use it before curing composites or luting to prevent the oxygen inhibition layer from forming. BLO2X Oxygen Blocker allows removal of luting resins closer to the final contour before curing, thus eliminating the need to address a large excess of cured composite or luting cement.
Use DeOx® to prevent negative contour in areas where oxygen DeOx®: inhibition of resin polymerization results in premature material loss.
Use it before curing composites or luting to prevent the oxygen inhibition laver from forming. DeOx® allows removal of luting resins closer to the final contour before curing, thus eliminating the need to address a large excess of cured composite or luting cement.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service .
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Vincent M. Tentarelli Quality Assurance Manager Pascal Company, Inc. 2929 N.E. Northup Way Bellevue, WA 98004
OCT 2 2 2010
Re: K102526
Trade/Device Name: BLO2X Oxygen Blocker Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: September 1, 2010 Received: September 2, 2010
Dear Mr. Tentarelli:
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 - Mr. Tentarelli
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 device-related 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for
Anthony D. Watson, B.S., M.S., M.B.A. 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
OCT 2 2 2010
510(k) Number (if known): K102526
Device Name: BLO2X Oxygen Blocker
Indications for Use:
BLO2X Oxygen Blocker is intended to prevent negative contour in areas where oxygen inhibition of resin polymerization results in premature material loss. Use it before curing composites or luting to prevent the oxygen inhibition layer from forming. BLO2X Oxygen Blocker allows removal of luting resins closer to the final contour before curing, thus eliminating the need to address a large excess of cured composite or luting cement.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ruser Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: JC102526
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.