FDA.report

POCL

Primary DI
D779100CL1
Brand
POCL
Company
COSMEDENT, INC.
Model
100CL
Published
2020-01-24
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
EJBHandle, Instrument, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EJBHandle, Instrument, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D779100CL1PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental plastic restoration carverA hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental plastic restorations, e.g., for cutting, scraping, paring, and smoothing finishes and fashioning patterns (non-patient-contact). It will typically be a double-ended metal instrument with a solid blunt blade/nib of various sizes and designs with a central handle. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
113911689
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
D7796722B01Bulkfill6722B02022-03-08
D7796722C31Bulkfill6722C32022-03-08
D7796722D21Bulkfill6722D22022-03-08
D7796722351Bulkfill6722352022-03-01
D7796722A11Bulkfill6722A12022-03-01
D7796722A21Bulkfill6722A22022-03-01
D7796722A31Bulkfill6722A32022-03-01
D7796722B11Bulkfill6722B12022-03-01
D779203101116 Gauge Black Tips2031012021-11-11
D7792031021018 Gauge Pink Tips2031022021-11-11
D7792031031119 Gauge Silver Tips2031032021-11-11
D7792031041222 Gauge Black Tips2031042021-11-11
D77920320212Mixing Tips CosmeCore 8gTips2032022021-11-11
D77920320413MirrorImage 10:1 Tips2032042021-11-11
D77920320515Adhere 1:1 Tips2032052021-11-11
D77920320615Connect 4:1 Tips2032062021-11-11
D77920330211CosmeCore IntraOral Tips2033022021-11-11
D77920340213White Plastic Nozzle Tips2034022021-11-11
D77920350315CosmeCore 50g Tip Package2035032021-11-11
D77970351T1Impressiv 5:1 Putty Cartridge Tips70531T2021-11-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00348783010206Premier Mirror HandlesPREMIER DENTAL PRODUCTS COMPANYEJB2026-03-17
G1493807306TBS DentalACME ENTERPRISE.EJB2026-03-02
00841013120459Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EJB2026-01-06
00841013120466Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EJB2026-01-06
30371347019668Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
30371347019675Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
30371347019682Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
30371347019699Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
00371347017724Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
00371347017748Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
00883205032164Slide PackerULTRADENT PRODUCTS, INC.EJB2025-08-21
00883205032157Slide PackerULTRADENT PRODUCTS, INC.EJB2025-08-19
08806343925183ever KITShinhung MST Co., Ltd.EJB2025-07-28
08806343925213TAPER KITShinhung MST Co., Ltd.EJB2025-07-28
08806343925220GUIDE KITShinhung MST Co., Ltd.EJB2025-07-28
08057639710567Specialist OrganizerMC BIO SRLEJB2025-06-23
08057639710574Tip with Indexable StopMC BIO SRLEJB2025-06-23
08057639710598Offset Tip SPMC BIO SRLEJB2025-06-23
08057639710604Long Tip SPMC BIO SRLEJB2025-06-23
08057639710628GBR MODULAR SETMC BIO SRLEJB2025-06-23
08057639712066Handle - Straight MDFMC BIO SRLEJB2025-06-23
08057639712073Handle - Straight - ErgalMC BIO SRLEJB2025-06-23
08057639712080Handle - Straight SP (TiN)MC BIO SRLEJB2025-06-23
08057639712097Handle - Asym. - ErgalMC BIO SRLEJB2025-06-23
08057639712103Handle - Asym. - SP (TiN)MC BIO SRLEJB2025-06-23
08057639712110Handle - Asym. - TitaniumMC BIO SRLEJB2025-06-23
08056992093119Starter SetMC BIO SRLEJB2025-06-20
08056992093126Basic SetMC BIO SRLEJB2025-06-20
08056992093133Advance SetMC BIO SRLEJB2025-06-20
08806343922328Short Drill KitShinhung MST Co., Ltd.EJB2025-06-16