Crown, Preformed
Dental · 21 CFR 872.3330
Recent MDR events
22 adverse event reports on file
- DENTAL CROWNMar 15, 2023InjuryUnkMW5115771
- CROWN ON TOOTH #19Mar 1, 2023InjuryUnkMW5115299
- 3M ESPE STAINLESS STEEL PRIMARY MOLAR CROWNAug 10, 2017Injury3m Espe Dental Products3005174370-2017-00044
- 3I INCISE ZR COPING SHADE 2Dec 11, 2015MalfunctionBiomet 3i0001038806-2015-00870
- 3I INCISE ZR 3 UNIT FRAMEWORK SHADE 4Jun 5, 2015MalfunctionBiomet 3i0001038806-2015-00701
- 3I INCISE ZR 6 UNIT FRAMEWORK SHADE 0Mar 12, 2015MalfunctionBiomet 3i0001038806-2015-00431
- 3I INCISE ZR COPING SHADE 2Mar 10, 2015MalfunctionBiomet 3i0001038806-2015-00331
- 3I INCISE ZR COPING SHADE 3Feb 4, 2015MalfunctionBiomet 3i0001038806-2015-00060
- 3I INCISE ZR COPING SHADE 2Jan 13, 2015MalfunctionBiomet 3i0001038806-2015-00013
- 3M ESPE STAINLESS STEEL CROWN, PRIMARY MOLARJan 14, 2013Injury3m Espe Dental Products3005174370-2013-00001
Event type breakdown
Recalls
4 recall events for this product code
- 3M Company - Health Care BusinessTerminatedNov 27, 2013
3M ESPE, Unitek Stainless Steel Permanent Molar Crowns
3M is recalling specific lots of 3M ESPE Unitek Primary Stainless Steel Crowns - Series UR4 contain LL3 crowns which are incorrectly labeled as UR4 crowns.
Z-0428-2014 · View FDA record ↗ - 3M Company/3m Espe Dental ProductsTerminatedAug 27, 2013
3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code 902150 (Kit- 112 crowns/kit) and 900114 (Refill- 5 crowns/box).
3M ESPE is recalling Unitek Primary Stainless Steel Crowns (First Primary UL4) because these products have been manufactured with the incorrect marginal contour edge.
Z-2100-2013 · View FDA record ↗ - 3M Company / Medical DivisionTerminatedNov 26, 2010
3M ESPE Stainless Steel Primary Molar Crowns, Made in USA by 3M ESPE Dental Products, St Paul, MN.
Unitek Stainless Steel Permanent Crowns with product Codes 902150, 900213, and 900223, is mislabeled. The crown contained within the package is incorrectly labeled; series UL3 crowns are labeled series UR3 and vice versa. The lid of the package correctly identified the product number and lot. This mislabeling could result in placement on the right side of a crown intended for use on the left, and
Z-0463-2011 · View FDA record ↗ - 3M Company / Medical DivisionTerminatedJan 24, 2008
3M ESPE Unitek Stainless Steel Permanent Molar Crowns , Product Code: 900321, Made in U.S.A by 3M ESPE Dental Products St. Paul, MN 55144-1000.
Mislabeled: Unitek Stainless Steel Permanent Molar Crowns were placed in packaging which incorrectly identified the product as Unitek Stainless Steel Primary Molar Crowns.
Z-0569-2008 · View FDA record ↗
Registered firms
134 firms currently registered for this product code
White Bite, Inc.
Parrish, FL, US
Dylan Lucas International Inc
Vaughan Ontario, CA
Samtrade Supplies Inc.
TORONTO Ontario, CA
Solventum Us Llc
Irvine, CA, US
Xdent Lab Co. Ltd
Can Giuoc Commune Tay Ninh, VN
Ocean Ceramics
Aldergrove British Columbia, CA
Innovaid Co.
Seoul, KR
Creodent Hudson Valley
Fishkill, NY, US
Isomedix Operations, Inc.
Libertyville, IL, US
Frasaco Gmbh
TETTNANG Baden-Wurttemberg, DE
Kelsey Dental Llc
The Woodlands, TX, US
Foo Tian Dental Laboratory
Shenzhen Guangdong, CN
J C India
Rajkot Gujarat, IN
Smileconcept Dental Lab
Seoul, KR
Veenak International Limited
BIRMINGHAM, GB
Parkell, Inc.
EDGEWOOD, NY, US
Shenzhen Sunmc Dental Technology Co., Ltd.
Shenzhen Guangdong, CN
Dentac, Llc
Dallas, TX, US
Crown Makers
Seoul, KR
Oketz Logistics Llc
Coral Gables, FL, US
Prime Dental Manufacturing, Inc.
CHICAGO, IL, US
Dsc Dental, Llc
Saint George, UT, US
Hass Corp.
Gangneung-si Gangwon, KR
Laxmi Dental Limited
Palghar Maharashtra, IN
Crown Trading (hk) Co., Limited
HONG KONG, CN
510(k) clearances
9 clearances for this product code
- Ez-Pedo, Inc.Jun 29, 2009
K091362 · CERAMIC PEDATRIC PREFORMED CROWN
- South American Dental Exporting Corp.Jul 22, 1994
K932759 · TEMPOARY POLYCARBONATE CROWNS
- George M. Wilson, DdsJul 21, 1993
K931352 · PEDO JACKETS OR PJ'S
- George M. Wilson, DdsSep 30, 1991
K913152 · WHITER BITER CROWN
- George M. Wilson, DdsSep 16, 1991
K912686 · WHITER BITER CROWN
- Svenska Dental Instruments ABJun 6, 1989
K892893 · SDI POLYCARBONATE CROWN, SCHEIN'S
- Whitecap Dental Co.Sep 16, 1988
K883325 · PERFORMED CROWN (STAINLESS STEEL)
- Sterndent Corp.Jul 15, 1977
K771128 · NEKO CERAMIC CONVENIENCE CROWNS