Nitanium Pro Form Archwires,Round,Square,Rectangul
FDA 510(k) K931663 · Ortho Organizers, Inc.
510(k) numberK931663
Submission
- Device name
- Nitanium Pro Form Archwires,Round,Square,Rectangul
- Applicant
- Ortho Organizers, Inc.
San Marcos, CA, US - Received
- April 5, 1993
- Decision date
- July 8, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K994357 | Bitem Lock, Models SW006, SW012EJF · Traditional | Thermoelastic Technologies, Inc. | 03/14/2000SE |
| K932825 | Microarch Gold BracketEJF · Traditional | Gac Intl., Inc. | 05/09/1994SE |
| K933501 | AlastikEJF · Traditional | Unitek Corp. | 04/28/1994SE |
| K923372 | Memory WireEJF · Traditional | Althan, Inc. | 04/22/1994SE |
| K933080 | Orthotech Dura-Gold BarcketsEJF · Traditional | Orthotech | 03/23/1994SE |
| K935139 | Fascination Ceramic BracketEJF · Traditional | Dentauraum, Inc. | 02/04/1994SE |
| K936244 | Regency BracketEJF · Traditional | Mid-American Dental Specialties, Inc. | 02/02/1994SE |
| K934881 | ReflectionsEJF · Traditional | Cdb Corp. | 02/01/1994SE |
| K935122 | Dentaurum Metal BracketsEJF · Traditional | Dentauraum, Inc. | 01/31/1994SE |
| K926427 | Lariat Palate ExpanderEJF · Traditional | Easy Access Orthodontics, Inc. | 01/26/1994SE |
More from Easy Access Orthodontics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252760 | Carriere® Motion Pro® Clear Bite CorrectorDYW · Traditional | 11/27/2025SE |
| K173440 | Carriere SLX 3D ClearNJM · Traditional | 03/08/2018SE |
| K160720 | Carriere Motion Clear Class IIDYW · Traditional | 11/28/2016SE |
| K110335 | Ceramic BracketsNJM · Traditional | 05/19/2011SE |
| K061266 | Ortho Organizers Temporary Orthodontic AnchorOAT · Traditional | 07/31/2006SE |
| K923218 | Nitanium Palatal ExpanderEJF · Traditional | 09/13/1993SE |
| K931980 | Stainless Steel Orthodontic ProductsDYO · Traditional | 09/01/1993SE |
Questions and answers
When was Nitanium Pro Form Archwires,Round,Square,Rectangul cleared by the FDA?
Nitanium Pro Form Archwires,Round,Square,Rectangul (K931663) received a 510(k) decision of Substantially Equivalent on July 8, 1993, 94 days after the submission was received.
What is the product code of K931663?
The FDA product code is EJF – Bracket, Metal, Orthodontic, a Class I (low risk) device regulated under 21 CFR 872.5410.