Who is the manufacturer of HYCEM APLICAP?

Espe GmbH & Co. Kg. filed the 510(k) submission for HYCEM APLICAP (K963737).

What is the FDA product code for HYCEM APLICAP?

EMA. It is classified under 21 CFR 872.3275 as a Class 2 device in the Dental panel.

What is the regulatory pathway for HYCEM APLICAP?

510(k) clearance (submission type: Traditional).

What are the predicate devices for HYCEM APLICAP?

Advance™ Hybrid Ionomer Cement (Dentsply Caulk).

Who can help prepare an FDA 510(k) submission like HYCEM APLICAP?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

HYCEM APLICAP

K963737 · Espe GmbH & Co. Kg. · EMA · Nov 15, 1996 · Dental

Device Facts

Record ID	K963737
Device Name	HYCEM APLICAP
Applicant	Espe GmbH & Co. Kg.
Product Code	EMA · Dental
Decision Date	Nov 15, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3275
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Hycem® Aplicap® is intended for final cementation of restorations composed of all classes of materials, including for cementation of crowns, bridges, inlays/onlays, pins and screws, and brackets and bands.

Device Story

Hycem® Aplicap® is a compomer luting cement; used for final cementation of dental restorations (crowns, bridges, inlays/onlays, pins, screws, brackets, bands). Applied by dental professionals in clinical settings. Provides adhesive fixation of prosthetic components to tooth structure. Benefits include secure retention of dental restorations.

Clinical Evidence

Bench testing only; compliance with DIN and ISO standards for dental cement demonstrated.

Technological Characteristics

Compomer luting cement; composition and physical properties verified against DIN and ISO standards for dental materials.

Indications for Use

Indicated for final cementation of dental restorations including crowns, bridges, inlays, onlays, pins, screws, brackets, and bands in patients requiring restorative dental procedures.

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

Advance™ Hybrid Ionomer Cement (Dentsply Caulk)

Related Devices

K974458 — COMPOLUTE APLICAP · Espe Dental-Medizin GmbH & Co.Kg. · Feb 2, 1998
K974140 — ADHESIVE HYBRID IONOMER CEMENT · Dentsply Intl. · Jan 5, 1998
K981813 — PERMACEM AUTOMIX LUTING CEMENT SYSTEM · Foremost Dental Mfg., Inc. · Jul 10, 1998
K160800 — DuoCem · Coltene/Whaledent AG · Nov 16, 2016
K020256 — UNICEM · 3M Espe AG Dental Products · Mar 25, 2002

Submission Summary (Full Text)

{0} NOV 15 1996 K963737 # II. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS ESPE is submitting a 510(k) premarket notification for its compomer luting cement, tradenamed Hycem® Aplicap®. Hycem® Aplicap® is intended for final cementation of restorations composed of all classes of materials, including for cementation of crowns, bridges, inlays/onlays, pins and screws, and brackets and bands. ESPE is claiming substantial equivalence to Dentsply Caulk’s Advance™ Hybrid Ionomer Cement. These products have the same intended use and similar composition. To support the substantial equivalence to predicate products, the composition and the physical and technical characteristics of Hycem® Aplicap® have been compared to those of Advance™ Hybrid Ionomer Cement. Hycem® Aplicap® meets the requirements of relevant DIN and ISO standards for dental cement. ESPE’s 510(k) has been submitted on September 17, 1996 by Dr. Barbara Wagner at Am Griesberg 2, D-82229 Seefeld, Germany (011-49-8152-700395). 401A/6473S.1