Who is the manufacturer of KETAC-MOLAR APLICAP?

Espe GmbH & Co. Kg. filed the 510(k) submission for KETAC-MOLAR APLICAP (K960954).

What is the FDA product code for KETAC-MOLAR 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 KETAC-MOLAR APLICAP?

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

What are the predicate devices for KETAC-MOLAR APLICAP?

Ketac-Bond® Aplicap® (K874788); Ketac-Silver® Aplicap® (K843566).

Who can help prepare an FDA 510(k) submission like KETAC-MOLAR 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.

KETAC-MOLAR APLICAP

K960954 · Espe GmbH & Co. Kg. · EMA · May 16, 1996 · Dental

Device Facts

Record ID	K960954
Device Name	KETAC-MOLAR APLICAP
Applicant	Espe GmbH & Co. Kg.
Product Code	EMA · Dental
Decision Date	May 16, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3275
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Ketac-Molar® Aplicap® is a glass ionomer cement material indicated for the following uses: 1. linings for Class I and II cavities filled with composite; 2. core build-ups; 3. fillings in deciduous teeth; 4. fillings in Class I cavities located in non-occlusal load bearing areas; 5. fillings in Class V cavities if the aesthetics are not of primary importance; and 6. temporary fillings in Class I and II cavities.

Device Story

Glass ionomer cement material; modification of Ketac-Bond® Aplicap® and Ketac-Silver® Aplicap®; designed for improved compressive strength. Used by dental professionals in clinical settings for restorative procedures; provides structural support and filling material for various cavity classes and core build-ups. Applied via Aplicap® delivery system; hardens to provide dental restoration. Benefits include enhanced mechanical properties compared to predecessors while maintaining established glass ionomer clinical utility.

Clinical Evidence

Bench testing only. Comparison of physical and technical characteristics and water-soluble fluoride content against predicate devices. Compliance with relevant DIN and ISO standards for dental cement confirmed.

Technological Characteristics

Glass ionomer cement material; improved formulation for higher compressive strength. Meets relevant DIN and ISO standards for dental cement. Delivered via Aplicap® system.

Indications for Use

Indicated for dental patients requiring cavity linings (Class I/II), core build-ups, deciduous tooth fillings, non-occlusal Class I cavity fillings, Class V fillings (where aesthetics are secondary), and temporary fillings for Class I/II cavities.

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

Ketac-Bond® Aplicap® (K874788)
Ketac-Silver® Aplicap® (K843566)

Related Devices

K973262 — KETAC-FIL APLICAP PLUS · Espe GmbH & Co. Kg. · Nov 17, 1997
K101493 — ADVANCED GLASS IONOMER (K-130) RESTORATIVE · Dentsply International, Inc. · Aug 19, 2010
K153174 — Ketac Universal Aplicap · 3M Deutschland GmbH · Apr 13, 2016
K982779 — MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1 · Medental Intl. · Sep 30, 1998
K123826 — VITRO MOLAR · Dfl Industria E Comercio SA · Feb 14, 2013

Submission Summary (Full Text)

{0} K960954 ## II. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ESPE is submitting a 510(k) premarket notification for modifications to its 510(k) submissions for dental cement material, tradenamed Ketac-Bond® Aplicap® (K874788) and Ketac-Silver® Aplicap (K843566), to create slightly modified glass ionomer cement material, referred to by the tradename Ketac-Molar® Aplicap®. The reason for this modification is to provide for an improved compressive strength. Ketac-Molar® Aplicap® is a glass ionomer cement material indicated for the following uses: 1. linings for Class I and II cavities filled with composite; 2. core build-ups; 3. fillings in deciduous teeth; 4. fillings in Class I cavities located in non-occlusal load bearing areas; 5. fillings in Class V cavities if the aesthetics are not of primary importance; and 6. temporary fillings in Class I and II cavities. ESPE is claiming substantial equivalence to its previously cleared Ketac-Bond® Aplicap® and Ketac-Silver® Aplicap® products. These products have similar intended uses and, in the case of Ketac-Bond® Aplicap®, the same principal ingredient composition. To support substantial equivalence to predicate products, the physical and technical characteristics, as well as the water soluble fluoride content, of Ketac-Molar® Aplicap® have been compared to those of Ketac-Bond® Aplicap® and Ketac-Silver®. W401A/A31059.1 - 2 - {1} Aplicap®. Ketac-Molar® Aplicap® meets the requirements of relevant DIN and ISO standards for dental cement. ESPE's 510(k) has been submitted on March 6, 1996, by Dr. Barbara Wagner at Am Griesberg 2, D-82229 Seefeld, Germany (011-49-8152-700395). WADIA/A21059.1 - 3 - 3