Cerec 2

FDA 510(k) K950299 · Pelton & Crane Co.

Substantially Equivalent

510(k) numberK950299

Submission

Device name
Cerec 2
Applicant
Pelton & Crane Co.
Charlotte, NC, US
Received
January 25, 1995
Decision date
May 23, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
ELW – Material, Impression
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3660
Specialty
Dental

Other 510(k)s with product code ELW

510(k)DeviceApplicantDecision
K254112Dia-X Sil BiteELW · Traditional DiaDent Group International03/19/2026SE
K253501Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set -…ELW · Traditional Vigodent Indústria E Comercio Ltda10/31/2025SE
K250969Jet Bite; Jet Blue Bite Fast; Jet Blue Bite SuperfastELW · Abbreviated Dent4you AG06/27/2025SE
K241924Elastic Impression MaterialELW · Abbreviated Beijing Okvd Biological Technology , Ltd.12/27/2024SE
K242360Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal…ELW · Traditional Dent4you AG11/15/2024SE
K233954Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-BluELW · Traditional B&E Korea Co., Ltd.02/13/2024SE
K223892DentMix VPS Impression MaterialELW · Traditional Innovative Product Brands, Inc.04/27/2023SE
K213175No Stress ImpressELW · Traditional No Stress Impress, LLC01/19/2023SE
K214086Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite…ELW · Traditional Genoss Co., Ltd.12/15/2022SE
K222741DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular…ELW · Traditional Hdi, Inc.11/07/2022SE

More from Hdi, Inc.

510(k)DeviceDecision
K171872P50 Series Dental Operative Unit and AccessoriesEIA · Traditional 04/26/2018SE
K143696SpiritEIA · Traditional 09/18/2015SE
K972249Orthophos Plus and Orthophos Plus/CdEHD · Traditional 09/12/1997SE
K972168Sidexis Digital Radiography SystemEHD · Traditional 09/05/1997SE
K945117DeltaFLE · Traditional 02/28/1997SE
K962071Spirit S1/S2EIA · Traditional 08/06/1996SE
K960819Heliodent DSEAP · Traditional 03/29/1996SE
K946187Spirit II and Spirit Treatment CenterEIA · Traditional 03/01/1995SE
K950030Heliodent MDEAP · Traditional 02/03/1995SE
K936068Orthophos 3/ Orthophos 3CEAP · Traditional 07/29/1994SE

Questions and answers

When was Cerec 2 cleared by the FDA?

Cerec 2 (K950299) received a 510(k) decision of Substantially Equivalent on May 23, 1995, 118 days after the submission was received.

What is the product code of K950299?

The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.