FDA.report

IS TIP

Primary DI
08800019110446
Brand
IS TIP
Company
B& L Biotech, inc.
Model
STS5A5
Published
2022-10-14
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

Related Records

Product Codes

CodeName
JETPick, Massaging

Product Code Classifications

CodeDeviceSpecialtyClass
JETPick, MassagingDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800019110446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800019110446088000191104468800019110446

GMDN Terms

TermDefinition
Dental implant/teeth debridement brush, biodegradableA rotary/oscillating dental instrument intended to be used by a dental hygienist and/or dentist for the non-surgical-invasive debridement of a patient's dental implants and/or teeth affected by peri-implant disease (peri-implant mucositis, peri-implantitis) or periodontitis. It is a brush-like device with biodegradable (e.g., chitosan) bristles at the distal end of a high-grade steel shaft. It is intended to be connected to a dental handpiece which provides the rotation or oscillation for the mechanical removal of biofilm from the surface of the implants and teeth. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
687338285
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
08800019151012BL Clamp CLAMP1 2025-07-18
08800019151029BL Clamp CLAPM12A2025-07-18
08800019151036BL Clamp CLAMP13A2025-07-18
08800019151043BL Clamp CLAMP2012025-07-18
08800019151050BL Clamp CLAMP2102025-07-18
08800019151067BL Clamp CLAMP2112025-07-18
08800019116608NeoGlide Resin InstrumentsNGR#12025-06-18
08800019116615NeoGlide Resin InstrumentsNGR#22025-06-18
08800019151289PVS TipPVSA2025-04-30
08800019151296PVS TipPVSE2025-04-30
08800019151302PVS TipPVSC2025-04-30
08800019151548Endodontic ExplorerENEX2025-04-30
08800019151555Dental Mirror HandleDMHG2025-04-30
08800019151562Pro Endo Mirror PEM2025-04-30
08800019151586Dental MirrorDMF42025-04-30
08800019151593DB TipDB-0A2025-04-30
08800019151609DB TipDB-3A2025-04-30
08800019151616DB TipDB-0E2025-04-30
08800019151623DB TipDB-3E2025-04-30
08800019151630DS TipDS-XLA2025-04-30

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Primary DIBrandCompanyProduct codePublished
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08800019151296PVS TipB& L Biotech, inc.JET2025-04-30
08800019151302PVS TipB& L Biotech, inc.JET2025-04-30
08800019151593DB TipB& L Biotech, inc.JET2025-04-30
08800019151609DB TipB& L Biotech, inc.JET2025-04-30
08800019151616DB TipB& L Biotech, inc.JET2025-04-30
08800019151623DB TipB& L Biotech, inc.JET2025-04-30
08800019151630DS TipB& L Biotech, inc.JET2025-04-30
08800019151647DS TipB& L Biotech, inc.JET2025-04-30
08800019151654DS TipB& L Biotech, inc.JET2025-04-30
08800019151661DS TipB& L Biotech, inc.JET2025-04-30
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08800019151685TS TipB& L Biotech, inc.JET2025-04-30
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08800019151708TS TipB& L Biotech, inc.JET2025-04-30
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08800019151340DS TipB& L Biotech, inc.JET2024-12-05
08800019151357DS TipB& L Biotech, inc.JET2024-12-05
08800019151364DS TipB& L Biotech, inc.JET2024-12-05
08800019151371DS TipB& L Biotech, inc.JET2024-12-05
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