GC Tion Gingival Protector
FDA 510(k) K043301 · GC America, Inc.
510(k) numberK043301
Submission
- Device name
- GC Tion Gingival Protector
- Applicant
- GC America, Inc.
Alsip, IL, US - Received
- November 30, 2004
- Decision date
- January 25, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EIE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K182118 | armor LCEIE · Traditional | Mavrik Dental Systems, Ltd. | 05/03/2019SE |
| K151945 | Triumph Resin DamEIE · Traditional | Denali Corporation | 02/18/2016SE |
| K050318 | Bari-Kad Packing DeviceEIE · Traditional | Bioenvelop Agro, Inc. | 03/04/2005SE |
| K040797 | Britesmile Masking CreamEIE · Special | Britesmile, Inc. | 04/02/2004SE |
| K022522 | Pulpdent Putty DamEIE · Traditional | Pulpdent Corporation | 09/26/2002SE |
| K021524 | Light Cure Dental DamEIE · Traditional | Prime Dental Manufacturing, Inc. | 07/19/2002SE |
| K021613 | Niveous Liquid DamEIE · Traditional | Shofu Dental Corp. | 06/20/2002SE |
| K010935 | Britesmile Barrier MaterialEIE · Traditional | Britesmile, Inc. | 09/05/2001SE |
| K983227 | Power BlockEIE · Traditional | Kreativ, Inc. | 12/11/1998SE |
| K972775 | FastdamEIE · Traditional | Interdent, Inc. | 02/27/1998SE |
More from Interdent, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K262202 | Cerasmart ForteEBF · Traditional | 09/10/2026SE |
| K253317 | Cytrans ElashieldLYC · Traditional | 07/06/2026SE |
| K261246 | SRGC-06EBF · Traditional | 06/18/2026SE |
| K254109 | G-Cem UniversalEMA · Traditional | 05/18/2026SE |
| K251124 | G-Bond UniversalKLE · Traditional | 10/02/2025SE |
| K250953 | Equia LC OneEMA · Traditional | 09/19/2025SE |
| K251946 | G aenial Universal Injectable IIEBF · Traditional | 08/29/2025SE |
| K200798 | G-Cem OneEMA · Traditional | 11/24/2020SE |
| K200682 | BZF-29KLE · Traditional | 10/02/2020SE |
| K192597 | Cytrans GranulesLYC · Abbreviated | 08/17/2020SE |
Questions and answers
When was GC Tion Gingival Protector cleared by the FDA?
GC Tion Gingival Protector (K043301) received a 510(k) decision of Substantially Equivalent on January 25, 2005, 56 days after the submission was received.
What is the product code of K043301?
The FDA product code is EIE – Dam, Rubber, a Class I (low risk) device regulated under 21 CFR 872.6300.