FDA.reportPublic FDA data

Gentle Hand-Bur Systems

Primary DI
00860007700842
Brand
Gentle Hand-Bur Systems
Company
DENTAL CARE FOR ALL INTERNATIONAL
Model
C4
Device description
"C4: Our clamp-lock system (ideally) uses a tray-set of 4 handles with bur sizes #2,4,6,8. These pen-style, pin vise (PSPV) aluminum handles securely anchor 2 mm in diameter HP 44.5 mm dental burs. Perforated ""Pin-Lock"" handles twist-tighten (with a locking-pin) a micro-chuck assembly (MCA) bur-anchoring mechanism. The MCA is coupled with a smooth grip clamp-lock tightening device which grips the MCA's outer collar (compression sleeve) for counter pressure tightening with the locking pin. Testing has proven that supplemental mechanical force makes it impossible for a bur to loosen while in use. "
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
00860007700842PrimaryGS10
00860007700866Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007700842008600077008428600077008420860007700842
00860007700866008600077008668600077008660860007700866

GMDN Terms#

Term, Definition table
TermDefinition
Manual non-rotary dental instrument handleA hand-held, manual device designed to hold and facilitate manipulation of a non-powered, non-rotary dental instrument (e.g., endodontic file/rasp, implant extractor). It is designed to accept the patient-contact endpiece (not included) for ease of handling. 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
4
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860007700811Gentle Hand-Bur SystemsKC2022-03-24
00860007700880Gentle Hand-Bur SystemsP42022-06-05
00196852155521Gentle Hand-Bur SystemsP12022-07-09
00860007700804Gentle Hand-Bur SystemsP22022-03-24
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
D955BBGA351Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BBGA451Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BBGA551Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BBGA701Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BONDNG1Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
00810226102231AiraAIRA, LLCDZN2026-08-26
00810226102248AiraAIRA, LLCDZN2026-08-26
00198506092688ELMED INCORPORATEDELMED INCORPORATEDDZN2026-07-28
E0HM39MI2071Bone ManagementHager & Meisinger Gesellschaft mit beschränkter HaftungDZN2026-07-24
E0HM39MI2081Bone ManagementHager & Meisinger Gesellschaft mit beschränkter HaftungDZN2026-07-24
00190776403867MillenniumAvalign Technologies, Inc.DZN2026-07-21
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