1200/1 to 1240/15 Various Types of Dental Scalers
FDA 510(k) K851721 · Artiberia
510(k) numberK851721
Submission
- Device name
- 1200/1 to 1240/15 Various Types of Dental Scalers
- Applicant
- Artiberia
San Antonio, TX, US - Received
- April 25, 1985
- Decision date
- July 2, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EMN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070127 | Plaque Scraper-A Interproximal (Between Teeth) Plaque Remover, Model Z01, Z02EMN · Traditional | Kevin Vu, Dds | 03/29/2007SE |
| K931330 | Dental Instruments ScalerEMN · Traditional | Minnesota Prophy Power, Inc. | 01/26/1994SE |
| K821786 | Beach ScalersEMN · Traditional | Pacific Dental Corp. | 07/06/1982SE |
| K781035 | Periodontal Instrument #21 Goldman-FoxEMN · Traditional | Premier Dental Products Co. | 06/30/1978SE |
More from Premier Dental Products Co.
| 510(k) | Device | Decision |
|---|---|---|
| K851745 | 1-100 Universal Set Otoscope & Larynx Exploraton BERA · Traditional | 08/29/1985SE |
| K851786 | 27-230 to 27-234 Various Cast Breakers, WolfLGG · Traditional | 07/09/1985SE |
| K851730 | 2710 to 2935 Various Pliers for Orthodontics/ProstEJY · Traditional | 07/02/1985SE |
| K851729 | 2620/1 to 2635/2 Various Dental Crown ScissorsEIR · Traditional | 07/02/1985SE |
| K851727 | 2020-1/2 to 2220 Various Dental Wax & Modelling CaEIK · Traditional | 07/02/1985SE |
| K851726 | 1760/1 to 2010/34 Various Dental Filling InstrumenEIY · Traditional | 07/02/1985SE |
| K851724 | 1410/1 to 1435/13 Various Probes & ExplorersEKB · Traditional | 07/02/1985SE |
| K851723 | 1300/10 to 1305/89-92 Various Cutting InstrumentsEKD · Traditional | 07/02/1985SE |
| K851722 | 1285/5 to 1295 Various Types of Dental ExcavatorsEKC · Traditional | 07/02/1985SE |
| K851720 | 1155/1 to 1162/12 Various Types Gum ScissorsEGN · Traditional | 07/02/1985SE |
Questions and answers
When was 1200/1 to 1240/15 Various Types of Dental Scalers cleared by the FDA?
1200/1 to 1240/15 Various Types of Dental Scalers (K851721) received a 510(k) decision of Substantially Equivalent on July 2, 1985, 68 days after the submission was received.
What is the product code of K851721?
The FDA product code is EMN – Scaler, Periodontic, a Class I (low risk) device regulated under 21 CFR 872.4565.