Fiberfill SGP
FDA 510(k) K023819 · Pentron Clinical Technologies
510(k) numberK023819
Submission
- Device name
- Fiberfill SGP
- Applicant
- Pentron Clinical Technologies
Wallingford, CT, US - Received
- November 15, 2002
- Decision date
- March 26, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K073369 | Ei Downpak Barrier SleevesEKM · Traditional | Hu-Friedy Mfg. Co., Inc. | 02/27/2008SE |
| K070246 | Down PakEKM · Special | Endo Twinn B.V. | 02/16/2007SE |
| K051573 | TGP (Gutta Percha Containing Tetracycline or Doxycycline)EKM · Traditional | Dr. Howard Martin, P.A. | 06/26/2006SE |
| K042870 | Endo TwinnEKM · Traditional | Endo Twinn B.V. | 01/11/2005SE |
| K971641 | Antibacterial Gutta PerchaEKM · Traditional | Dr. Howard Martin, P.A. | 07/21/1997SE |
| K970134 | Thermaprep Plus OvenEKM · Traditional | Tulsa Dental Products, Ltd. | 03/21/1997SE |
| K931742 | Inject-R FillEKM · Traditional | Union Broach, Div. Moyco Industries, Inc. | 05/27/1993SE |
| K924825 | Microdose Rc-EzEKM · Traditional | Unicep | 03/05/1993SE |
| K915243 | Touch 'N Heat Model 5002, ModificationEKM · Traditional | Analytic Technology | 01/21/1992SE |
| K910224 | ThermaprepEKM · Traditional | Tulsa Dental Products, Ltd. | 03/29/1991SE |
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| K091512 | Build-It Light CureEBF · Traditional | 10/30/2009SE |
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| K072830 | RM Bond, Model J032DYH · Traditional | 12/04/2007SE |
| K072480 | Generation 8 Se AdhesiveKLE · Traditional | 11/21/2007SE |
| K072545 | Artiste Se Flowable Composite, Model N280EBF · Traditional | 10/26/2007SE |
| K071500 | Nano-Bond II Adhesive SystemKLE · Traditional | 08/10/2007SE |
| K060889 | Se Epiphany Root Canal Sealant, Model N59SEKIF · Traditional | 10/27/2006SE |
| K060698 | Cement-It All Purpose, Model N97EMA · Traditional | 05/10/2006SE |
| K052106 | Simile FlowEBF · Traditional | 10/31/2005SE |
| K052349 | Avante LED Curing Unit, Model N44EBZ · Traditional | 10/21/2005SE |
Questions and answers
When was Fiberfill SGP cleared by the FDA?
Fiberfill SGP (K023819) received a 510(k) decision of Substantially Equivalent on March 26, 2003, 131 days after the submission was received.
What is the product code of K023819?
The FDA product code is EKM – Gutta-Percha, a Class I (low risk) device regulated under 21 CFR 872.3850.