FDA.reportPublic FDA data

#23/CP-12 Color Coded Explorer, Periodontal Probe

Primary DI
00810060723166
Brand
#23/CP-12 Color Coded Explorer, Periodontal Probe
Company
Berman Instruments LLC
Model
PX312
Published
2022-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KAKProbe, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAKProbe, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810060723166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810060723166008100607231668100607231660810060723166

GMDN Terms#

Term, Definition table
TermDefinition
Dental explorerA hand-held manual dental instrument designed for tactile examination (i.e., exploration) in the oral cavity, on the tooth surface and/or gums, mainly to find indentations (e.g., pits, fissures) for the determination of early tooth decay on the crown of teeth; it is also used in periodontology (e.g., to locate subgingival deposits before scaling). It is a long, slender instrument (a manual probe) with a stem that terminates in a thin working part at the distal end which may be needle-like, hooked, or blunt according to the intended use. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
118744340
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00810060722015Adson Tissue ForcepsAF0012022-09-22
00810060722039Aspirating Syringe 1.8 mlAS0182022-09-22
00810060722077Lucas Curette #85BC085 2022-09-22
00810060722084Lucas Curette #87BC0872022-09-22
00810060722091Lucas Curette #88BC0882022-09-22
008100607221072R/2L Columbia Curette CC022 2022-09-22
008100607221144R/4L Columbia Curette CC044 2022-09-22
0081006072212113/14 Columbia CuretteCC1342022-09-22
008100607221381/2 Gracey CG012 2022-09-22
0081006072214511/12 Gracey CG112 2022-09-22
0081006072215213/14 Gracey CG134 2022-09-22
0081006072220613K/TG Kirkland Periodontal ChiselCKP13 2022-09-22
008100607222204 Ochsenbein Surgical Chisel, 3.4 mmCOS04 2022-09-22
00810060722237College Pliers, Serrated Tips CP001 2022-09-22
00810060722244113 Non-serrated Cord Packer CP113 2022-09-22
00810060722251College Pliers, Self-locking, Serrated Tips CPL02 2022-09-22
00810060722558Rubber dam punch DF002 2022-09-22
00810060722657Molt #2 Surgical CuretteEP002 2022-09-22
00810060722930Molt Mouth Prop - Adult MA002 2022-09-22
00810060722947Metal Bowl - Prep CupMBPC352 2022-09-22

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