# K031664: Elements Obturation Unit

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Endo/Analytic
- Decided: Apr 28, 2004 after 335 days
- Product code: EKR (Plugger, Root Canal, Endodontic)
- Device class: 1
- Regulation: 21 CFR 872.4565
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) System B HeatSource: named in the summary without a submission number
- (no number) Obtura II: named in the summary without a submission number

## Most influential descendants
- K042828: Obtura Gutta Percha Delivery System, Model 823-700 (2004), 1 descendant of its own
- K060347: B&L L-Beta, Model WL-B1 (2006), 0 descendants of its own

## Recalls of this device
- Dec 27, 2017 · Class II · Z-0413-2018: Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU).
- Jan 17, 2013 · Class II · Z-1544-2013: A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Unit and its Replacemen
- Jan 17, 2013 · Class II · Z-1545-2013: A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Unit and its Replacemen

## Indications for use
The Elements Obturation Unit is intended to be used in Dentistry to: 1. Provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus, 2. For tissue cauterization and coagulation, and 3. To backfill and downpack gutta percha during Endodontic root canal treatment. 4. When in Extruder mode, the Elements Obturation Unit is used only to backfill gutta percha during root canal obturation.

Source page: https://510kreport.com/device/K031664
Methodology: https://510kreport.com/methodology