← Product Code [EMA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA) · K974097 # PERIACRYL (K974097) _Blacklock Medical Products, Inc. · EMA · Apr 9, 1998 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K974097 ## Device Facts - **Applicant:** Blacklock Medical Products, Inc. - **Product Code:** [EMA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA.md) - **Decision Date:** Apr 9, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3275 - **Device Class:** Class 2 - **Review Panel:** Dental ## Indications for Use Periacryl™ is indicated for use as a dental cement for bonding dental materials such as crowns, caps and pins. ## Device Story Periacryl™ is a dental cement composed of N-Butyl 2 Cyanoacrylate. It is used by dental or medical practitioners to bond dental materials, specifically crowns, caps, and pins. The device is supplied non-sterile. It functions via chemical adhesion. The practitioner applies the cement to the dental materials to facilitate bonding within the oral cavity. The device benefits the patient by providing a secure adhesive for dental restorations. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Material: N-Butyl 2 Cyanoacrylate. Form: Dental cement. Sterilization: None claimed (non-sterile). ## Regulatory 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. 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. ## Predicate Devices - Indermil™ Dental (Loctite) ## Reference Devices - Tissu-Glu ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K974097 # SUMMARY OF SAFETY AND EFFECTIVENES APR - 9 1998 PERIACRYLTM The Summary of Safety and Effectiveness of PERIACRYL™ dental cement reflects data available and presented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth. ### Intended Use Periacryl™ is indicated for use as a dental cement for bonding dental materials such as crowns, caps and pins. #### Caution Federal law (U.S.A.) restricts this device to sale to and use by a qualified dental or medical practitioner. ### Contraindications: Periacry]™ must not come in contact with the conjunctival sac since conglutination may occur. ## Identification of predicate devices: IndermilTM Dental (Loctite, Rocky Hill, CT 06067) # Substantial Equivalency Information The Blacklock Medical Product's Periacryl™ dental cement is similar to the Indermil™ Dental cement currently offered by Loctite. As a further note, Tissu-Glu is another cyanoacrylate that has been offered for sale in the United States by Ellman International, Hewlitt New York since prior to 1976. This product is sold non sterile as is Periacryl™ | | Loctite | Blacklock | |---------------|-----------------------------|--------------------------| | Materials | N-Butyl 2 Cyanoacrylate | N-Butyl 2 Cyanoacrylate | | Sterilization | Gamma Radiation
SAL 10-6 | Sterility is not claimed | The intended use and technological characteristics of these devices do not vary significantly. The safety and effectiveness of the Blacklock Medical Product's PeriacryI™ dental cement are comparable to that of the Loctite's Indermil™ Dental cement. {1}------------------------------------------------ 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR - 9 1998 Mr. Don Blacklock ·President Blacklock Medical Products, Incorporated 6671 London Court V4K 4W7 Delta, British Columbia CANADA Re : K974097 Trade Name: Periacryl Requlatory Class: II Product Code: EMA Dated: January 13, 1998 Received: January 16, 1998 Dear Mr. Blacklock: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of {2}------------------------------------------------ Page 2 - Mr. Blacklock the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to beqin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdalgov/cdrh/dsmamain.html". Sincerely yours Timothy A. Ulatowski Directd Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ K974097/51 Page **_/ of _**/ ... 510(k) Number (if known): K9740 97 Device Name: Indications For Use: 05/01/98 PeriacryI™ is indicated for use as a dental cement for bonding dental materials such as crowns, caps, and pins. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) SeRunner (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number KG974097 Prescription User (Per 21 CFR 801.109) ଠନ୍ନ Over-The-Counter Use_ (Optional Format 1-2-96) SK=65 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K974097](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K974097) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com