FDA.reportPublic FDA data

Straight Handpiece

Primary DI
00850000738485
Brand
Straight Handpiece
Company
NAKAMURA DENTAL K.K.
Model
ESG-30AR-T
Device description
1/4 Reducer
Published
2025-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850000738485PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850000738485008500007384858500007384850850000738485

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
701248445
Device count
1
Premarket exempt
true
Serial number
true
Sterilization required before use
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250337120131Diamond Abrasor, Ball Tip, CoarseJoimax GmbHHWE2026-11-03
04250337120704Diamond Abrasor, Ball TipJoimax GmbHHWE2026-11-03
04250337122333Olive Cutter, Olive Tip, with side protectionJoimax GmbHHWE2026-11-03
00763000777418CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-11-01
00763000777517CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-11-01
00763000777524CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-11-01
00763000774165CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774172MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774189MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774196MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774202MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774226MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774240MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774257MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774301MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000777692MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000777739MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
09421038413753Enztec Modular Planer Handle - ZimmerENZTEC LIMITEDHWE2026-10-30
09421038413760Enztec Modular Planer Handle - Large AOENZTEC LIMITEDHWE2026-10-30
09421038413777Enztec Modular Planer Handle - HudsonENZTEC LIMITEDHWE2026-10-30
09421038413784Enztec Modular Planer 38mm – 7.10mm IDENZTEC LIMITEDHWE2026-10-30
09421038413791Enztec Modular Planer 38mm – 8.00mm IDENZTEC LIMITEDHWE2026-10-30
09421038413807Enztec Modular Planer 45mm – 7.10mm IDENZTEC LIMITEDHWE2026-10-30
09421038413814Enztec Modular Planer 45mm – 8.00mm IDENZTEC LIMITEDHWE2026-10-30
09421038413821Enztec Modular Planer 45mm – 8.10mm IDENZTEC LIMITEDHWE2026-10-30
09421038413838Enztec Modular Planer 38mm – 8.10mm IDENZTEC LIMITEDHWE2026-10-30
04250337121794"Shrill® Deflector Shaft 2, WL= 320mm, reusable"Joimax GmbHHWE2026-10-29
04250337122388Deflector Bone Resector, Bullet-Tip, disposableJoimax GmbHHWE2026-10-29
04250337122395Deflector Diamond Abrasor, disposableJoimax GmbHHWE2026-10-29
04250337122401Deflector Bone Resector, Ball-Tip, disposableJoimax GmbHHWE2026-10-29