Who is the manufacturer of EBS (ESPE BONDING SYSTEM)?

Espe GmbH & Co. Kg. filed the 510(k) submission for EBS (ESPE BONDING SYSTEM) (K962428).

What is the FDA product code for EBS (ESPE BONDING SYSTEM)?

KLE. It is classified under 21 CFR 872.3200 as a Class 2 device in the Dental panel.

What is the regulatory pathway for EBS (ESPE BONDING SYSTEM)?

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

Who can help prepare an FDA 510(k) submission like EBS (ESPE BONDING SYSTEM)?

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.

EBS (ESPE BONDING SYSTEM)

K962428 · Espe GmbH & Co. Kg. · KLE · Sep 12, 1996 · Dental

Device Facts

Record ID	K962428
Device Name	EBS (ESPE BONDING SYSTEM)
Applicant	Espe GmbH & Co. Kg.
Product Code	KLE · Dental
Decision Date	Sep 12, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3200
Device Class	Class 2

Intended Use

The EBS® System is intended to bond composite materials to the tooth structure, and is composed of an etching gel, primer and bonding agent.

Device Story

3-component resin tooth bonding system; includes etching gel, primer, and bonding agent. Used by dentists to facilitate adhesion of composite materials to tooth structure. System components are applied sequentially to prepare tooth surface for composite restoration. Benefits include improved retention of dental composites.

Clinical Evidence

Bench testing only; shear bond strength comparison performed between EBS® System and 3M Scotchbond™ Multi-Purpose Dental Adhesive System.

Technological Characteristics

3-component dental adhesive system consisting of etching gel, primer, and bonding agent. Chemical composition identical to predicate primer.

Indications for Use

Indicated for dental patients requiring bonding of composite restorative materials to tooth structure.

Regulatory Classification

Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Predicate Devices

3M's Scotchbond™ Multi-Purpose Dental Adhesive System (K920424)

Reference Devices

ESPE MiniTip Etching Gel (K810266)
ESPE Pertac® Universal Bond (K904289)

Related Devices

K020050 — ENAMEL BONDING SYSTEM · Rite-Dent Manufacturing Corp. · Feb 14, 2002
K231696 — Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal · Prevest Denpro Limited · Aug 11, 2023
K983414 — EVERBOND · Espe Dental AG · Dec 16, 1998
K051796 — CLEARFIL TRI-S BOND SINGLE DOSE · Kuraray Medical Kurashiki Plant · Aug 9, 2005
K962785 — 3M DENT SYSTEM · 3M Company · Aug 12, 1996

Submission Summary (Full Text)

{0} SEP 12 1996 K962428 ## II. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS ESPE is submitting a 510(k) premarket notification for its 3-component resin tooth bonding system, tradenamed EBS® (ESPE Bonding System). The EBS® System is intended to bond composite materials to the tooth structure, and is composed of an etching gel, primer and bonding agent. The etching gel used in the EBS® System is ESPE's 510(k) cleared MiniTip Etching Gel (K810266), and the bonding agent used in the EBS® product is ESPE's 510(k) cleared Pertac® Universal Bond (K904289), tradenamed EBS® Bond. The primer used in the EBS® product, tradenamed EBS® Primer, is substantially equivalent to the primer in 3M's Scotchbond™ Multi-Purpose Dental Adhesive System (K920424). Both products have identical ingredient compositions and the same intended uses. To support substantial equivalence to 3M's predicate product, the shear bond strength of the EBS® System has been compared to that of the Scotchbond™ System. ESPE's 510(k) has been submitted on June 24, 1996, by Dr. Barbara Wagner at Am Griesberg 2, D-82229 Seefeld, Germany (011-49-8152-700395). W401A/A40418.1