# K072554: Access and Rotamax Fiber Optic High Speed Dental Handpieces

- Pathway: 510(k) (Abbreviated)
- Applicant: Sable Industries, Inc.
- Decided: Nov 14, 2007 after 65 days
- Product code: EFB (Handpiece, Air-Powered, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K983183 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983183: Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora, Aquilon, MC2,MC3, Basch, Isolite, Optima, US, Plpe, CA, P, Bien Air USA, Inc. (1998) Summary page 1.

## Indications for use
Sable Industries Fiber Optic High Speed Dental Handpieces & Accessories are indicated for the preparation of dental cavities for restorations, such as fillings.

Source page: https://510kreport.com/device/K072554
Methodology: https://510kreport.com/methodology