FDA.report

Spot it

Primary DI
17310236901102
Brand
Spot it
Company
Directa AB
Model
Straight
Catalog number
690110
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EJBHandle, Instrument, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EJBHandle, Instrument, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
17310236901102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1731023690110217310236901102

GMDN Terms

TermDefinition
Dental articulation paperA strip or sheet of suitable material coated with pigment and used for marking areas of contact between opposite teeth, restorations or appliances. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
353954381
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
false

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17310230400304Ceramir Crown & Bridge QuikCap102572024-03-28
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17310230400373Ceramir BIC QuikCap102912024-03-28
17310230400328Ceramir Crown & Bridge QuikMix400322024-03-28
17310230021318LuxatorLK4506330U2022-12-07
17310230021325LuxatorLK7506331U2022-12-07
17310230021332LuxatorLK VET506332U2022-12-07
17310230021424LuxatorSK4506333U2022-12-07
17310230021622LuxatorP Kit506635U2022-12-07
17310230021585LuxatorP1506631U2022-12-07
17310230021592LuxatorP2506632U2022-12-07
17310230021608LuxatorP3506633U2022-12-07
17310230021615LuxatorP4506634U2022-12-07
17310230021493LuxatorL2S TiN506434U2022-12-07

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