Gentle Hand-Bur Systems

Primary DI
00860007700804
Brand
Gentle Hand-Bur Systems
Company
DENTAL CARE FOR ALL INTERNATIONAL
Model
P2
Device description
"P2: A “P2” dental hand-bur handle, is a ""premium"" locking-handle which consists of a round, threaded, aluminum handle which embodies a heavy-duty micro-chuck assembly (MCA). The MCA embodies a threaded end which screws into the handle’s internal threads in order to secure a dental bur so it cannot dislodge while in use. To secure a dental bur after insertion, a bur-locking-wrench grips the MCA and is counter-tightened by a locking pin at the handle’s opposite end. The MCA’s outer sleeve embodies two locking grooves (or slots) that engage a 7 mm bur-locking “wrench” or “key.” The casing is made of durable, 2 mm 6061-T6 medical grade aluminum designed for maximum strength and longevity. Rightly classed as a “premium” model, it can withstand the demands of repeated bur-tightening common to a busy dental practice engaged in chair-side bur changing. Learn more about our mission at dentalcareforall.org. If you have any complaints with our products please call or email us for immediate resolution: email team@dcfai.org / Call +19562801708 (WhatsApp)"
Published
2022-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZNInstruments, Dental Hand

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860007700804PrimaryGS10
00860007700828Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007700804008600077008048600077008040860007700804
00860007700828008600077008288600077008280860007700828

GMDN Terms#

Term, Definition table
TermDefinition
Dental excavator, reusableA hand-held manual dental instrument designed for cutting, scraping, and removing the carious dentine of a decayed tooth or other pathological bone tissue within the oral cavity. It is made of high-grade stainless steel typically designed as a double-ended instrument, having a central handle, with small, sharp, spoon-, scoop-, or spatula-shaped blades that have sharp cutting/gouging edges. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+9562801708team@gentlehandburs.com

Regulatory Flags#

DUNS number
118270502
Device count
2
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860007700842Gentle Hand-Bur SystemsC42022-03-24
00860007700811Gentle Hand-Bur SystemsKC2022-03-24
00860007700880Gentle Hand-Bur SystemsP42022-06-05
00196852155521Gentle Hand-Bur SystemsP12022-07-09
00860007700873Gentle Hand-Bur SystemsE12022-03-24
00860007700897Gentle Hand-Bur SystemsP42022-06-05
00860007700835Gentle Hand-Bur SystemsKC2022-03-24
00860007700866Gentle Hand-Bur SystemsC42022-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10860013564701CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564718CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564725CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564732CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564756CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564763CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564770CurvaGc Orthodontics America Inc.DZN2026-05-28
07898488905190INSTRUMENT FOR ICERAM SLB BRACKETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
07908611211187CERAMIC NANO TUBE TWEEZERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
07908611211255CURVERD SCISSORS FOR ALIGNERSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
G149TBSB7500TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7510TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7520TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7530TBS BASICSACME ENTERPRISE.DZN2026-05-21
08404535018929Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535018950Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019049Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019070Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019131Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019162Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
07908854000647Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000654Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000661Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000678Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000838Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000883Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000890Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001040Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001071Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001163Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22