FDA.report

Caulk® Super Bur®

Primary DI
D0026657100
Brand
Caulk® Super Bur®
Company
DENTSPLY INTERNATIONAL INC.
Model
665710
Catalog number
665710
Device description
Caulk® Super Bur® Round I Bur No. 2 - Slow Speed
Published
2022-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EJLBUR, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D0026657101PrimaryHIBCC0
D0026657100Unit of UseHIBCC0

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
083235549
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00810126508294Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508300Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508317Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508324Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
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