FDA.reportPublic FDA data

Optomic

Primary DI
08436041580010
Brand
Optomic
Company
OPTOMIC ESPAÑA SA
Model
OP-DENT Microscope (240)
Published
2024-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EPTMicroscope, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPTMicroscope, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08436041580010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08436041580010084360415800108436041580010

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical microscopeA light (optical) magnification instrument intended to be used to magnify and visualize minute intraoral structures during dental examination and dental surgical procedures via transmission of white and/or ultraviolet light. It typically consists of a control unit, eyepiece and magnification controls, and a white and fluorescent light module to enable differentiation of natural tooth material suggesting dental pathology (e.g., caries, plaque, calculus/tartar) or composite material used for dental repairs. It may also include a camera for still image capture or video recording.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
564165678
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08436041580485OptomicOP-30 Naso-pharyngoscope2024-08-01
08436041580089OptomicOP-C12 COLPOSCOPE (45) 2024-07-18
08436041580096OptomicOP-C16 COLPOSCOPE (45) 2024-07-18
08436041580102OptomicOP-C5 COLPOSCOPE 2024-07-18
08436041580119OptomicOP-C2L COLPOSCOPE 2024-07-18
08436041580126OptomicOP-C2 COLPOSCOPE 2024-07-18
08436041580362OptomicOP-S10 CHAIR 2024-07-18
08436041580379OptomicOP-S8 CHAIR 2024-07-18
08436041580386OptomicOP-S6 CHAIR 2024-07-18
08436041580393OptomicOP-S7 CHAIR 2024-07-18
08436041580409OptomicOP-S4 CHAIR 2024-07-18
08436041580416OptomicOP-S10 CHAIR (STRUCTURE) 2024-07-18
08436041580423OptomicOP-S8 CHAIR (STRUCTURE)2024-07-18
08436041580430OptomicOP-S6 CHAIR (STRUCTURE) 2024-07-18
08436041580447OptomicOP-S7 CHAIR (STRUCTURE)2024-07-18
08436041580454OptomicOP-S4 CHAIR (STRUCTURE)2024-07-18
08436041580461OptomicOP-G7+ CHAIR (GOEPEL) 2024-07-18
08436041580478OptomicOP-G7+ CHAIR (FOOT SUPPORTS) 2024-07-18
08436041580522OptomicOTOSCOPE OPT 1,9mm x 100mm x 0 AUT.2024-07-18
08436041580539OptomicOTOSCOPE OPT 1,9mm x 100mm x 30 AUT.2024-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00890446104932OSSEOUS-Endoscrub 4 mm ( 0° )EON MEDITECH PRIVATE LIMITEDEPT2026-03-13
00860014850509HMDmd Wearable Surgical MonitorHMDMD INC.EPT2025-11-22
07630003501421M320 Optics CarrierLeica Microsystems (Schweiz) AGEPT2025-10-22
07630003501629M320 Optics CarrierLeica Microsystems (Schweiz) AGEPT2025-10-22
07630003501636M320 Optics CarrierLeica Microsystems (Schweiz) AGEPT2025-10-22
07630003501643M320 Optics CarrierLeica Microsystems (Schweiz) AGEPT2025-10-22
07630802405906ARveo 8xLeica Microsystems (Schweiz) AGEPT2025-09-17
04547497753058Mielscope +YOSHIDA DENTAL MFG. CO., LTD., THEEPT2025-09-01
B366U1OM200CLR02MICROSCOPEEclerisEPT2025-06-30
B366U1OM200CR02MICROSCOPEEclerisEPT2025-06-30
B366U1OM200FLR02MICROSCOPEEclerisEPT2025-06-30
B366U1OM200FR02MICROSCOPEEclerisEPT2025-06-30
B366U1OM200TLR02MICROSCOPEEclerisEPT2025-06-30
B366U1OM200TR02MICROSCOPEEclerisEPT2025-06-30
B366U1OM200WLR02MICROSCOPEEclerisEPT2025-06-30
B366U1OM200WR02MICROSCOPEEclerisEPT2025-06-30
06941877821456EighteethChangzhou Sifary Medical Technology Co., Ltd.EPT2025-04-17
04048551432099NAKarl Storz GmbH & Co. KGEPT2025-03-28
04048551432105NAKarl Storz GmbH & Co. KGEPT2025-03-28
04048551432174NAKarl Storz GmbH & Co. KGEPT2025-03-28
04048551432518NAKarl Storz GmbH & Co. KGEPT2025-03-28
04048551469262NAKarl Storz GmbH & Co. KGEPT2025-03-28
06977585090051EXTARO 300Carl Zeiss Meditec (Suzhou) Co., Ltd.EPT2025-03-26
06977585090099EXTARO 300Carl Zeiss Meditec (Suzhou) Co., Ltd.EPT2025-03-26
06977585090129EXTARO 300Carl Zeiss Meditec (Suzhou) Co., Ltd.EPT2025-03-26
06977585090136EXTARO 300Carl Zeiss Meditec (Suzhou) Co., Ltd.EPT2025-03-26
00840183528461BR Surgical, LLCBR Surgical, LLCEPT2024-11-07
00840183528553BR Surgical, LLCBR Surgical, LLCEPT2024-11-05
00840183528546BR Surgical, LLCBR Surgical, LLCEPT2024-10-25
00840183528560BR Surgical, LLCBR Surgical, LLCEPT2024-10-24