FDA.report

COMPACTOR DRILL NR.4

Primary DI
08435389805083
Brand
COMPACTOR DRILL NR.4
Company
BIOTECHNOLOGY INSTITUTE SL
Model
COMP4
Published
2022-11-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EJLBur, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08435389805083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08435389805083084353898050838435389805083

GMDN Terms

TermDefinition
Titanium dental burA rotary cutting device, the working end of which is made from titanium (Ti), 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 and bone. It can also be used to cut metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
461665312
Device count
1
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
false
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 DIBrandModelCatalogPublished
08435389828952EXTRACTOR FOR IMPLANTS 8EXIM82026-01-30
08435389828969EXTRACTOR FOR IMPLANTS 9EXIM92026-01-30
08435389829027SHORT DRILL; Ø2,2 MMF22CS2026-01-30
08435389829034SHORT DRILL; Ø2,3 MMF23CS2026-01-30
08435389829041SHORT DRILL; Ø2,4 MMF24CS2026-01-30
08435389829058SHORT DRILL; Ø2,0 MMF20CS2026-01-30
08435389829096FLATTENING FRONT CUTTING SHORT DRILL; Ø5.5 FCFA55C2026-01-30
08435389830061EXTRA SHORT INITIAL DRILLFIXS2026-01-30
08435389830078EXTRA SHORT DRILL; Ø1,8 MMF18XS2026-01-30
08435389830085EXTRA SHORT DRILL; Ø1,8/2,5 MMF1825XS2026-01-30
08435389830092EXTRA SHORT DRILL; Ø2,5 MMF25XS2026-01-30
08435389830108EXTRA SHORT DRILL; Ø2,8 MMF28XS2026-01-30
08435389830115EXTRA SHORT DRILL; Ø3 MMF30XS2026-01-30
08435389830269HEATING OVEN H-PLUSBTI H-PLUS2026-01-30
08435389830276DRILL HOLDER FOR EXTRA SHORT DRILLSFFXS2026-01-30
08435389830320SHORT DRILL; Ø1.5 MMF15CS2026-01-30
08435389829706EXPANDED SQUARE INTERFACE; MULTI-IM ABUTMENT; WIDE PLATFORMISMIPAX2026-01-29
08435389829713EXPANDED SQUARE INTERFACE; UNIT ABUTMENT; WIDE PLATFORMISMIUPAX2026-01-29
08435389829843MULTI-IM ABUTMENT; INTERNA 3.0 PLATFORM; Ø3,5; H 4,5MMINTMIP335452026-01-29
08435389829850MULTI-IM ABUTMENT; INTERNA 3.0 PLATFORM; H 4,5MMINTMIP3452026-01-29

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Primary DIBrandCompanyProduct codePublished
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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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