FDA.reportPublic FDA data

dental diamond bur

Primary DI
D877J316MG20
Brand
dental diamond bur
Company
STRAUSS & CO - INDUSTRIAL DIAMONDS LTD
Model
J316M/G
Catalog number
J316M/G
Device description
Special Diamond Bur Fine Medium Green Color Mark ATT (NRP)
Published
2025-11-11
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
false

Product Codes#

Code, Name table
CodeName
DZPInstrument, Diamond, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZPInstrument, Diamond, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D877J316MG2PrimaryHIBCC0
D877J316MG20Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Diamond dental bur, reusableA rotary cutting device made of high-grade steel with the working end coated with particles of diamond, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
600028195
Device count
2
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D877M31SPSTM25Strauss OneM31SP/STMM31SP/STM2026-02-04
D877M31SPSTSC25Strauss OneM31SP/ST/SCM31SP/ST/SC2026-02-04
D877M31SSSSTC25Strauss OneM31S-SS/ST/CM31S-SS/ST/C2026-02-04
D877M31SSSSTM25Strauss OneM31S-SS/ST/MM31S-SS/ST/M2026-02-04
D877M31SSSSTSC25Strauss OneM31S-SS/ST/SCM31S-SS/ST/SC2026-02-04
D877M31STF25Strauss OneM31ST/FM31ST/F2026-02-04
D877M31STM25Strauss OneM31ST/MM31ST/M2026-02-04
D877M31STSC25Strauss OneM31ST/SCM31ST/SC2026-02-04
D877M32STC25Strauss OneM32STCM32STC2026-02-04
D877M32STF25Strauss OneM32ST/FM32ST/F2026-02-04
D877M32STM25Strauss OneM32ST/MM32ST/M2026-02-04
D877M32STSC25Strauss OneM32ST/SCM32ST/SC2026-02-04
D877M3STF25Strauss OneM3ST/FM3ST/F2026-02-04
D877M3STSC25Strauss OneM3ST/SCM3ST/SC2026-02-04
D877M41STC25Strauss OneM41ST/CM41ST/C2026-02-04
D877M41STSC25Strauss OneM41ST/SCM41ST/SC2026-02-04
D877M4STSC25Strauss OneM4ST/SCM4ST/SC2026-02-04
D877M5STM25Strauss OneM5ST/MM5ST/M2026-02-04
D877PR11RSTC25Strauss OnePR11R/STCPR11R/STC2026-02-04
D877PR11STC25Strauss OnePR11STCPR11STC2026-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630243660995Alpen DiamondsDent4You AGDZP2026-09-04
07630243661237Alpen DiamondsDent4You AGDZP2026-09-04
07630243662470Alpen DiamondsDent4You AGDZP2026-09-04
07630243662494Alpen DiamondsDent4You AGDZP2026-09-04
07630243662517Alpen DiamondsDent4You AGDZP2026-09-04
07630243662531Alpen DiamondsDent4You AGDZP2026-09-04
07630243662555Alpen DiamondsDent4You AGDZP2026-09-04
07630243662579Alpen DiamondsDent4You AGDZP2026-09-04
07630243662593Alpen DiamondsDent4You AGDZP2026-09-04
07630243662616Alpen DiamondsDent4You AGDZP2026-09-04
07630243662630Alpen DiamondsDent4You AGDZP2026-09-04
07630243662654Alpen DiamondsDent4You AGDZP2026-09-04
07630243662678Alpen DiamondsDent4You AGDZP2026-09-04
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07630243662715Alpen DiamondsDent4You AGDZP2026-09-04
07630243662739Alpen DiamondsDent4You AGDZP2026-09-04
07630243662753Alpen DiamondsDent4You AGDZP2026-09-04
07630243662777Alpen DiamondsDent4You AGDZP2026-09-04
07630243662791Alpen DiamondsDent4You AGDZP2026-09-04
07630243662814Alpen DiamondsDent4You AGDZP2026-09-04
07630243662838Alpen DiamondsDent4You AGDZP2026-09-04
07630243662852Alpen DiamondsDent4You AGDZP2026-09-04
07630243662876Alpen DiamondsDent4You AGDZP2026-09-04
07630243662890Alpen DiamondsDent4You AGDZP2026-09-04
07630243662913Alpen DiamondsDent4You AGDZP2026-09-04
07630243662937Alpen DiamondsDent4You AGDZP2026-09-04
07630243662951Alpen DiamondsDent4You AGDZP2026-09-04
07630243662975Alpen DiamondsDent4You AGDZP2026-09-04
07630243662999Alpen DiamondsDent4You AGDZP2026-09-04
07630243663019Alpen DiamondsDent4You AGDZP2026-09-04