# K960910: Indermil Dental

- Pathway: 510(k) (Traditional)
- Applicant: Loctite Corp.
- Decided: Mar 28, 1996 after 23 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Octyldent®: named in the summary without a submission number
- (no number) Iso-Dent®: named in the summary without a submission number

## Indications for use
Indermil™ Dental is indicated for use as a dental cement for bonding dental matenals, such as crowns, caps, and pins; or temporarily attaching a fiber to the surface of the tooth in a procedure to treat periodontal discase.

Source page: https://510kreport.com/device/K960910
Methodology: https://510kreport.com/methodology