COMPOLUTE APLICAP

K974458 · Espe Dental-Medizin GmbH & Co.Kg. · EMA · Feb 2, 1998 · Dental

Device Facts

Record IDK974458
Device NameCOMPOLUTE APLICAP
ApplicantEspe Dental-Medizin GmbH & Co.Kg.
Product CodeEMA · Dental
Decision DateFeb 2, 1998
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3275
Device ClassClass 2
AttributesTherapeutic

Intended Use

Adhesive cementation of (all-porcelain-, composite-, and metal-) inlays, onlays, crowns, bridges, passive, and threaded posts and veneers

Device Story

Compolute® Aplicap® is a composite luting cement used for the adhesive cementation of dental restorations including inlays, onlays, crowns, bridges, posts, and veneers. The device consists of powder and liquid components. It is intended for professional use by dentists in a clinical setting. The cement functions by providing an adhesive bond between the dental restoration and the tooth structure. Clinical benefit is derived from the secure fixation of prosthetic dental devices. Safety is supported by fluoride release data.

Clinical Evidence

Bench testing only. The device meets DIN, ISO, and ADA standards for dental cements. Fluoride release data provided.

Technological Characteristics

Composite luting cement composed of powder and liquid. Ingredients include strontium aluminum lanthanum fluoro silicate glass, pigment white 6, and phosphine oxide. Meets DIN, ISO, and ADA standards for dental cements.

Indications for Use

Indicated for adhesive cementation of all-porcelain, composite, and metal inlays, onlays, crowns, bridges, passive and threaded posts, and veneers in dental patients.

Regulatory Classification

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

Related Devices

Submission Summary (Full Text)

{0} K974458 II. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS FEB - 2 1998 ESPE is submitting a 510(k) premarket notification for its composite luting cement, tradenamed **Composite® Aplicap® Composite® Aplicap®** is indicated for the adhesive cementation of (all-porcelain-, composite-, and metal-) inlays, onlays, crowns, bridges, passive and threaded posts, and veneers. The product is composed of powder and liquid portions. For composition, ESPE is claiming substantial equivalence to its previously cleared dental cement **Sono®-Cem (K913966)** and tooth shade resin material **Pertac® II (K962440)**. The ingredients in ESPE’s **Composite® Aplicap®** are contained in **Sono®-Cem and/or Pertac® II**, with the exception of: (1) strontium aluminum lanthanum fluoro silicate glass, which is contained in ESPE’s **Ketac-Fil Aplicap Plus (K973262)**; and (2) pigment white 6 and phosphine oxide, which are contained in ESPE’s **Protemp® Garant temporary crown and bridge resin material (K950203)**. For indications, ESPE is claiming substantial equivalence to its **Sono®-Cem product**, **Kuraray Co. Ltd.’s Panavia® 21**, **Vivadent’s Variolink II**, **3M’s Scotchbond Resin Cement**, and **Kerr’s Nexus dental cements**, all of which have substantially similar intended uses. To support substantial equivalence to predicate products, the physical and technical characteristics of **Composite® Aplicap®** have been compared to the listed predicates. **Composite® Aplicap®** meets the requirements of DIN, ISO and ADA standards for dental cements. W401A/145407.1 {1} To support safe use of Compolute® Aplicap®, fluoride release data have been provided on the product. ESPE’s 510(k) has been submitted on November 25, 1997, by Dr. Barbara Wagner-Schuh at ESPE Platz, D-82229 Seefeld, Germany (011-49-8152-700395). W401A/145407.1 - 3 - {2} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB - 2 1998 Dr. Barbara Wagner-Schuh Regulatory Affairs ESPE Dental-Medizin GmbH & Company, KG ESPE Plaza D-82229 Seefeld, Germany Re: K974458 Trade Name: Compolute® Aplicap® Regulatory Class: II Product Code: EMA Dated: January 29, 1998 Received: January 29, 1998 Dear Dr. Wagner-Schuh: 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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 Register. Please note: this response to your premarket notification submission does {3} Page 2 - Dr. Wagner-Schuh not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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.fda.gov/cdrh/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4} # STATEMENT OF INDICATIONS FOR USE Device Name: Compolute® Aplicap® Indications for use: Adhesive cementation of (all-porcelain-, composite-, and metal-) inlays, onlays, crowns, bridges, passive, and threaded posts and veneers Susan Ruwe (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number K974458 Prescription Use ☑ OR Over-The-Counter Use ☐ W401A/145407.1
Innolitics
510(k) Summary
Decision Summary
Classification Order
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