Cool Temp Natural
FDA 510(k) K041098 · Coltene AG
510(k) numberK041098
Submission
- Device name
- Cool Temp Natural
- Applicant
- Coltene AG
New York, NY, US - Received
- April 27, 2004
- Decision date
- May 13, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K253380 | FLNT Base and FLNT TempEBG · Traditional | Liaoning Upcera Co., Ltd. | 03/02/2026SE |
| K251271 | TempFIT Temporary Crown and Bridge ResinEBG · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 06/23/2025SE |
| K243370 | DentaTOOTHEBG · Traditional | Asiga Pty, Ltd. | 05/05/2025SE |
| K243621 | Evoblock, PerléonEBG · Traditional | Evoden Indústria Comércio Importação E Exportação | 04/22/2025SE |
| K243951 | TEMP MASTER, PMMA-based dental resinEBG · Traditional | Taiwan Dental Materials Co., Ltd. | 02/21/2025SE |
| K242559 | Digital TempEBG · Traditional | Sprintray, Inc. | 11/26/2024SE |
| K231859 | PrimmaArtEBG · Traditional | Dentscare Ltda | 11/26/2024SE |
| K240538 | Premium Teeth ResinEBG · Traditional | Formlabs Ohio, Inc. | 07/19/2024SE |
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More from Dreve Denatmid GmbH
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| K022224 | Cool Bond Light Cured Bracket Adhesive SystemDYH · Traditional | 09/18/2002SE |
| K902392 | Coltosol Temporary Endodontic Filling MaterialEMA · Traditional | 08/28/1990SE |
| K882800 | Coltene President Jet Regular BodyELW · Traditional | 09/23/1988SE |
| K873671 | Coltene President Jet Impression Materials SystemEKS · Traditional | 10/27/1987SE |
| K870266 | Coltene Brilliant D.I. Direct Inlay SystemEBF · Traditional | 02/27/1987SE |
| K870047 | Coltene RapidELW · Traditional | 01/29/1987SE |
| K863998 | Coltene Jet-MixerEID · Traditional | 10/30/1986SE |
| K850036 | Coltene PreciseELW · Traditional | 02/08/1985SE |
| K840297 | Coltene Oralloy MagicapsEJJ · Traditional | 03/16/1984SE |
| K811767 | Coltene President Impression MaterialsELW · Traditional | 07/15/1981SE |
Questions and answers
When was Cool Temp Natural cleared by the FDA?
Cool Temp Natural (K041098) received a 510(k) decision of Substantially Equivalent on May 13, 2004, 16 days after the submission was received.
What is the product code of K041098?
The FDA product code is EBG – Crown And Bridge, Temporary, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3770.