# K983104: Norian Periodontal/Dental Cement (PDC)

- Pathway: 510(k) (Traditional)
- Applicant: Norian Corp.
- Decided: Feb 12, 1999 after 161 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K873689 (1987). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962548: BSM Bone Substitute Material Kit, Etex Corp. (1997) Summary page 1.
- K973789: Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair System (CRS) Bone Cement- 10CC, Norian Corp. (1998) Summary page 1.

## Most influential descendants
- K101827: Osteoscaf (2011), 1 descendant of its own
- K213260: CMFlexTM (2022), 0 descendants of its own

## Indications for use
Norian PDC Cement is intended to be used in the treatment of periodontal bone wall defects, extraction socket defects, and for repair of cysts or other defects in the alveolar ridge or wall.

Source page: https://510kreport.com/device/K983104
Methodology: https://510kreport.com/methodology