FDA.reportPublic FDA data

CA Tip

Primary DI
08800019151401
Brand
CA Tip
Company
B& L Biotech, inc.
Model
CA120-A
Published
2024-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DZMNeedle, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZMNeedle, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800019151401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800019151401088000191514018800019151401

GMDN Terms#

Term, Definition table
TermDefinition
Dental ultrasonic surgical system handpiece tipA removable endpiece intended to be attached to a dental ultrasonic surgical system handpiece, and makes contact with a patient while oscillating (vibrating) at high frequency in order to mechanically fragment and cut bone during dental surgery. The device is available in a variety of forms (e.g., flat serrated blade, ball head, nail head, or probe-like) and sizes, and is typically made of metal; it is not intended to be held directly (i.e., does not include a holder). It is used for implant site preparation, dental extraction, distraction, sinus lift, periodontal surgery, cyst removal, extraction of bone block, bone harvesting, osteoplasty, and osteotomy. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
687338285
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08053610773750EFFITECDENTALHITECDZM2026-08-06
08053610773781EFFITECTECNOFAR SPADZM2026-07-30
08053610773798EFFITECTECNOFAR SPADZM2026-07-30
08053610773804EFFITECTECNOFAR SPADZM2026-07-30
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06973042242841Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
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