(69 days)
No
The summary describes a dental cement and its physical properties, with no mention of AI or ML.
No
The device is described as an adhesive cement for dental applications, and there is no indication that it is intended to diagnose, cure, mitigate, treat, or prevent disease, or affect the structure or any function of the body as typically defined for therapeutic devices.
No
The device is a dental cement used for adhesive cementation of dental prosthetics, which is a treatment function, not a diagnostic one.
No
The device description explicitly states it is composed of "powder and liquid portions," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the adhesive cementation of dental restorations (inlays, onlays, crowns, bridges, posts, and veneers). This is a direct application within the body (or on a part of the body) for structural support and restoration.
- Device Description: The description of powder and liquid portions is consistent with dental cements used for bonding.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, disease, or condition. The device's function is purely mechanical/adhesive.
- Performance Studies: The performance studies focus on physical and technical characteristics relevant to dental cements (meeting standards, fluoride release), not diagnostic accuracy or analytical performance.
Therefore, this device falls under the category of a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Adhesive cementation of (all-porcelain-, composite-, and metal-) inlays, onlays, crowns, bridges, passive, and threaded posts and veneers
Product codes
EMA
Device Description
The product is composed of powder and liquid portions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
To support safe use of Compolute® Aplicap®, fluoride release data have been provided on the product.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The string appears to be "K974458". The characters are written in a cursive style, with some connections between the letters and numbers. The image is in black and white, with the characters appearing in black against a white background.
II. 510(K) SUMMARY OF SAFETY AND EF
FEB - 2 1998
ESPE is submitting a 510(k) premarket notification for its composite luting cement, tradenamed Compolute® Aplicap.® Compolute® Aplicap® is indicated for the adhesive cementation of (allporcelain-, 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 Compolute® Aplicap® are contained in Sono®-Cem and/or Pertace 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 Compolute® Aplicap® have been compared to the listed predicates. Compolute® Aplicap® meets the requirements of DIN, ISO and ADA standards for dental cements.
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).
2
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo features a stylized depiction of an eagle or bird-like figure, with its wings spread. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 2 1998
Dr. Barbara Wagner-Schuh Requlatory 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 Requlations, Title 21, Parts 800 to 895. A 3 394 1 substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. T Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 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 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.qov/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
Compolute® Aplicap® Device Name:
Indications for use: Adhesive cementation of (all-porcelain-, composite-, and metal-) inlays, onlays, crowns, bridges, passive, and threaded posts and veneers
Susan Rusve
(Division Sign-Off) Division of Dental, Infection Control, and General Hosp 510(k) Number CA ાપ
Prescription Use X_
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
WA01A/145407.1
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