Cavit-Lc

FDA 510(k) K972892 · Espe GmbH & Co. Kg.

Substantially Equivalent

510(k) numberK972892

Submission

Device name
Cavit-Lc
Applicant
Espe GmbH & Co. Kg.
Seefeld, DE
Received
August 5, 1997
Decision date
October 2, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EBF – Material, Tooth Shade, Resin
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3690
Specialty
Dental

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K261246SRGC-06EBF · Traditional GC America, Inc.06/18/2026SE
K261093DiafilEBF · Traditional DiaDent Group International06/02/2026SE
K261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW…EBF · Traditional DiaDent Group International05/19/2026SE
K260805Dual CoreEBF · Traditional Vericom Co., Ltd.05/11/2026SE
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K261356Dura-CrownEBF · Special Hangzhou SHINING3D Dental Technology Co., Ltd.04/27/2026SE

More from Hangzhou SHINING3D Dental Technology Co., Ltd.

510(k)DeviceDecision
K974231Position Penta, Position Penta QuickELW · Traditional 01/29/1998SE
K973513Sinfony Dentin, Opaque-Dentin, Enamel, Enamel Modifier, Transparent Opal,Sinfony Magic…EBF · Traditional 12/22/1997SE
K973262Ketac-Fil Aplicap PlusEMA · Traditional 11/17/1997SE
K963735Cojet SystemEBF · Traditional 11/27/1996SE
K963737Hycem AplicapEMA · Traditional 11/15/1996SE
K962428Ebs (Espe Bonding System)KLE · Traditional 09/12/1996SE
K962442Hytac Aplitip/Hytac OsbEBF · Traditional 09/11/1996SE
K962440Pertac Ii/Pertac II AplitipEBF · Traditional 09/11/1996SE
K960954Ketac-Molar AplicapEMA · Traditional 05/16/1996SE
K960547Dimension Penta/Dimension Garant L/Polyvinyl Siloxane AdhesiveELW · Traditional 03/15/1996SE

Questions and answers

When was Cavit-Lc cleared by the FDA?

Cavit-Lc (K972892) received a 510(k) decision of Substantially Equivalent on October 2, 1997, 58 days after the submission was received.

What is the product code of K972892?

The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.