(133 days)
PeriAcryl® 90, PeriAcry18 80, PeriAcry1 70, and PeriAcry16 60 are indicated to be used as an adjunct to temporarily assist in securing periodontal dressings.
The Family of PeriAcryl® is a formulated compound of the cyanoacrylate series. It is available in 90/10 butyl/octyl, 80/20, butyl/octyl, 70/30 butyl/octyl and 60/40 butyl/octyl formulations depending on the dentist's preference. The compound, which exists in monomeric form in the plastic containers, polymerizes extremely rapidly in the presence of anions, especially of hydroxyl ions [in the presence of water]. It has the ability to adhere to moist living tissues. It demonstrates a favorable tissue response and reveals no toxic or foreign body reaction in humans.
This submission for KO71484 is for a medical device (PeriAcryl®), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific metrics (like MRMC studies, standalone performance, training sets, etc.) is not applicable to this document.
The document describes the device as a formulated compound of the cyanoacrylate series, indicated as an adjunct to temporarily assist in securing periodontal dressings. The substantial equivalency information states that the device has the same intended use and technological characteristics as predicate devices and does not contain new ingredients raising additional safety and effectiveness concerns.
Therefore, I cannot provide a table of acceptance criteria or details of a study proving the device meets those criteria, as these concepts are inherent to the evaluation of AI/ML software performance, which is not the subject of this 510(k) summary.
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KO71484
510(k) SUMMARY
The Summary of Safety and Effectiveness on the GluStitch, Inc. Family of PeriAcry® reflects data available and represented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies and or tests may require alterations of the conclusions or recommendations set forth.
| Applicant | Don Blacklock |
|---|---|
| GluStitch, Inc. | |
| 7188 Progress Way, #307 | |
| Delta, British Columbia | |
| Canada V4G 1M6 | |
| Telephone | 800-667-2130 |
| Facsimile | 877-450-4000 |
| Date | August 1, 2007 |
| Name | Family of PeriAcryl® |
| Classification | Dental Cement, 21 CFR 872.3275 |
| Predicate: | K050658 Hager WorldWide, Inc., Hager Reso Pac PeriodontalDressing, market clearance date May 27, 2005; K974097 Blacklock Medical Products, Inc., Periacryl, marketclearance date April 9, 1998; and K030574 GluStitch, Inc., GluSeal, market clearance date August 21,2003. |
| Description | The Family of PeriAcryl® is a formulated compound of the cyanoacrylateseries. It is available in 90/10 butyl/octyl, 80/20, butyl/octyl, 70/30butyl/octyl and 60/40 butyl/octyl formulations depending on the dentist'spreference. The compound, which exists in monomeric form in theplastic containers, polymerizes extremely rapidly in the presence ofanions, especially of hydroxyl ions [in the presence of water]. It has theability to adhere to moist living tissues. It demonstrates a favorable tissueresponse and reveals no toxic or foreign body reaction in humans. |
| Intended Use | PeriAcryl® is indicated to be used as an adjunct to temporarily assist insecuring periodontal dressings. |
| Cautions: | CAUTION: Federal law (U.S.A.) restricts this device to sale by or onthe order of a dentist. |
| SubstantialEquivalencyInformation | The Family of PeriAcryl® has the same intended use and the sametechnological characteristics as the predicate devices listed. The chemicalformulation for the Family of PeriAcryl® does not contain any newingredients which raises additional safety and effectiveness concerns. Theidentified differences were determined to be minor and did not raise anyconcerns regarding the overall safety and effectiveness of the device. |
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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 stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Don Blacklock President GluStitch, Incorporated 7188 Progress Way, 307# Delta, British Columbia CANADA V4G 1M6
Re: K071484
Trade/Device Name: PeriAcry1®90, PeriAcry1® 80, PeriAcry1® 70, and PeriAcry1® 60 Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: September 17, 2007 Received: September 26, 2007
OCT 1 0 2007
Dear Mr. Blacklock:
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. Blacklock
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 vours.
Syrite y. Michaeloud.
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 (if known): K071484
Device Name: PeriAcryl® 90, PeriAcry1® 80, PeriAcry1® 70, and PeriAcry1® 60
Indications for Use:
PeriAcryl® 90, PeriAcry18 80, PeriAcry1 70, and PeriAcry16 60 are indicated to be used as an adjunct to temporarily assist in securing periodontal dressings.
Prescription Use × (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suva Bunno
(Orision Sign-Off) Civision of Anesthesiology, General Hospital, Intection Control, Dental Devices
510(k) Number: K071484
Page 1 of
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
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.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.