# K012316: Permacem / Permacem Dual

- Pathway: 510(k) (Abbreviated)
- Applicant: Dmg USA, Inc.
- Decided: Aug 23, 2001 after 31 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
Longest line of descent: 1 generation back to K924151 (1992). 8 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940914: New Luting Cement Material (NLC), Dentsply Intl. (1994) Summary page 1.
- K940513: Optibond, Kerr Corporation (Danbury) (1994) Summary page 1.
- K940030: Bisco Composite, Bisco, Inc. (1994) Summary page 1.
- K922249: Flexi-Flow Cement Natural, Essential Dental Systems, Inc. (1994) Summary page 1.
- K960464: C & B Metabond (Modification), Parkell, Inc. (1996) Summary page 1.
- K931309: Variolink, Ivoclar North America, Inc. (1993) Summary page 1.
- K946100: Fuji Duet, GC America, Inc. (1995) Summary page 1.
- K924151: Bisco D/C Resinomer, Bisco, Inc. (1992) Summary page 1.
- (no number) Dyract Cem: named in the summary without a submission number
- (no number) Cement-It: named in the summary without a submission number
- (no number) ABC Dual Adhesive Bridge Cement: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K943596: Vantage, for Adac Gamma Cameras, Adac Laboratories (1995). Our OCR of the scanned summary read K943596, FDA’s number for Vantage, for Adac Gamma Cameras (Adac Laboratories). Its FDA name has none of the distinctive words the summary uses for the device it names, “Duolink”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K121804: Provitemp, Dentotemp, Totalcem, Dentocem (2013), 1 descendant of its own
- K041960: Composite/Compomer Repair Kit (2004), 1 descendant of its own
- K162960: TotalC-Ram (2017), 0 descendants of its own
- K063444: Total Etch Bonding Agent (2007), 0 descendants of its own
- K030168: Agc Cem (2003), 0 descendants of its own

## Indications for use
PermaCem is a chemical cure compomer cement for permanent luting of metal, resin, or ceramic crowns, bridges, inlays and onlays. PermaCem Dual is a dual cure compomer cement for permanent luting of metal, resin, or ceramic crowns, bridges, inlays and onlays. PermaCem Dual can also be used for: Luting of orthodontic anchors and brackets Luting of abutments for dentures Core build-up Splinting of teeth in combination with wires, Kevlar or Ribbond-type materials Repair material for resin-based provisionals Bite registration material Occlusal individualisation of plastic bite rails

Source page: https://510kreport.com/device/K012316
Methodology: https://510kreport.com/methodology