# K081913: Metacem, Meta P&Bond, Metacem Silane Ceramic Primer

- Pathway: 510(k) (Traditional)
- Applicant: Meta Biomed Co., Ltd.
- Decided: Sep 5, 2008 after 64 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: 8 generations back to K931812 (1993). 47 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073173: Self-Adhesive Resin Cement, Dentsply Interntional (2008) Summary page 1.
- K060701: Biscem Translucent, Biscem Opaque, Bisco, Inc. (2006). Our reading of the summary gave K060703, FDA’s number for PMP4 BP Pro Blood Pressure Monitor (Card Guard Scientific Survival, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Biscem Translucent, Biscem Opaque”. Summary page 2.
- K060698: Cement-IT All Purpose, Model N97, Pentron Clinical Technologies (2006) Summary page 1.
- K053040: Paracem Universal DC, Coltene/Whaledent AG (2005) Summary page 1.
- K040906: Calibra Cement, Dentsply Intl. (2004) Summary page 1.
- K070215: Tokuyama Bond Force, Tokuyama Dental Corporation (2007) Summary page 3.
- K063557: Peak Bond, Model 5133, Ultradent Products, Inc. (2006) Summary page 3.
- K011159: One-Step Plus, Bisco, Inc. (2001) Summary page 3.
- K960823: Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent, Dentsply Intl. (1996) Summary page 3.
- K061906: Clearfil Ceramic Primer, Kuraray Medical, Inc. (2006) Summary page 5.
- K061322: Porcelain Primer, J. Morita USA, Inc. (2006) Summary page 5.
- K024356: Clearfil Silane Kit, Kuraray Medical, Inc. (2003) Summary page 5.
- K954708: Silane Primer, Sybron Dental Specialties, Inc. (1995) Summary page 5.

## Most influential descendants
- K171449: Metacem (2018), 1 descendant of its own
- K261166: Dia-Cem (2026), 0 descendants of its own
- K180802: Meta P&Bond (2018), 0 descendants of its own

## Indications for use
Adhesive cementation of: • Crowns & Bridges (ceramic, porcelain, composite and metals), · Inlays/onlays cementation, * Bonding of veneers or crown; PFM, also alumina & zirconia, · Endodontic post cementation, · Core build up. * A dental adhesive formulated to adhesively bond to hard tissues of the oral cavity, enamel and dentin, * Dentin-enamel primer/bonding agent for direct composite restorations * Indirect composite restorative luting system * Porcelain veneer luting system * Bonding composite to composite * Bonding composite to metal/amalgam * Adhesive amalgam restoration. Primer for surfaces of: * Crowns and bridges, ceramic, composite, porcelain, metal, * Pre-cured composite inlays and onlays, * Ceramic inlays and onlays, * Porcelain veneers, * Porcelain and metal prosthesis

Source page: https://510kreport.com/device/K081913
Methodology: https://510kreport.com/methodology