FDA.reportPublic FDA data

Caulk® Post & Core Kit

Primary DI
D00261I0001
Brand
Caulk® Post & Core Kit
Company
DENTSPLY INTERNATIONAL INC.
Model
61i000
Catalog number
61i000
Device description
Caulk® Post & Core Kit
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKPREAMER, PULP CANAL, ENDODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKPReamer, Pulp Canal, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D00261I0001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Crown surgical drill bit, reusableA shaft of metal with a hollow centre designed for overdrilling a surgical screw or screw shaft to expose it for its removal, with another instrument, when the screw head has become defective or detached. The device is commonly called a "hollow mill" or "crown drill", but may also be referred to as a "hollow reamer", and is designed as a cylindrical hollow shell with a thin wall that has saw teeth at the cutting edge. It is inserted into a surgical power tool for rotation. This device may also be used to obtain core bone biopsies. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight. Keep dry.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)532-2855MilfordDE-Customer-Service@dentsplysirona.com

Regulatory Flags#

DUNS number
083235549
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D0026243451Enhance® mini Finishing System6243456243452022-04-11
D0026243551Enhance® mini Finishing System6243556243552022-04-11
D0026243651Enhance® mini Finishing System6243656243652022-04-11
D0026243751Enhance® mini Finishing System6243756243752022-10-13
D0026243851Enhance® mini Finishing System6243856243852022-04-11
D002624550001Polytrays62455000624550002022-07-07
D002624550011Polytrays62455001624550012022-07-07
D002624550021Polytrays62455002624550022022-07-07
D002624551001Polytrays62455100624551002022-07-07
D002624551011Polytrays62455101624551012022-07-07
D002624551021Polytrays62455102624551022022-07-07
D002624551031Polytrays62455103624551032022-07-07
D002624551051Polytrays62455105624551052022-07-07
D0026076071Calibra® Bio Bioceramic Luting Cement6076076076072022-04-20
D0026590301Palodent® Sectional Matrix System6590306590302019-04-02
D0026590701Palodent® Sectional Matrix System6590706590702019-04-02
D0026631001AutoMate®6631006631002019-04-02
D0013010121Ceramco® 3Powder Opaque i2/i43010122016-09-21
D0013010211Ceramco® 3Powder Opaque D23010212016-09-21
D0013010311Ceramco® 3Powder Opaque Modifier Yellow3010312016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630049902770Reamer 21mm 055, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990104Reamer 29mm 008, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990128Reamer 29mm 010, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990142Reamer 29mm 015, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990166Reamer 29mm 020, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990180Reamer 29mm 025, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990203Reamer 29mm 030, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990227Reamer 29mm 035, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990241Reamer 29mm 040, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990265Reamer 29mm 045, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990289Reamer 29mm 050, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990302Reamer 29mm 055, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990326Reamer 29mm 060, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990340Reamer 29mm 070, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990364Reamer 29mm 080, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996595Reamer 21mm 008, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996601Reamer 21mm 010, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996618Reamer 21mm 015, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996625Reamer 21mm 020, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996632Reamer 21mm 025, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996649Reamer 21mm 030, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996656Reamer 21mm 035, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996663Reamer 21mm 040, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996670Reamer 21mm 045, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996687Reamer 21mm 050, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996694Reamer 21mm 055, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996700Reamer 21mm 060, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996717Reamer 21mm 070, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996724Reamer 21mm 080, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996731Reamer 25mm 008, pu: 6 pcsDiaswiss SAEKP2023-10-02