FDA.reportPublic FDA data

Spherodon +

Primary DI
07290012207648
Brand
Spherodon +
Company
SILMET LTD
Model
139472
Catalog number
139472
Device description
Dental Amalgam Alloy
Published
2016-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EJJAlloy, Amalgam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJJAlloy, AmalgamDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K760980000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K760980000DENTAL ALLOYAdp Intl., Inc.1976-11-15EJJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290012207648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290012207648072900122076487290012207648

GMDN Terms#

Term, Definition table
TermDefinition
Dental amalgamA dental restorative material used primarily to fill tooth cavities, prepared by mixing liquid mercury (Hg) with an alloy of fine particles, composed mainly of silver (Ag), tin (Sn) and copper (Cu). The amalgam may be in either powder or tablet form, or in capsules, with portions of alloy and mercury predosed by the manufacturer. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600071344
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290015358835ProLink1500051500052016-10-26
07290015358842ProLink SE15SEKT15SEKT2016-10-26
07290015358859ProLink15SEUN 15SEUN 2016-11-28
07290016787450ProEtch1901001901002016-10-13
07290016787467ProEtch 1901241901242016-10-13
07290016787474ProEtch1901601901602016-12-19
07290016787627ProLink1500021500022017-10-22
07290012207006Nogama O-110471O-1104712016-10-26
07290012207013Nogama O-110472 O-110472 2016-10-26
07290012207020Nogama O-110473O-1104732016-10-26
07290012207037Nogama O-111471O-1114712016-10-26
07290012207044Nogama O-111472O-1114722016-10-26
07290012207051Nogama O-111473O-1114732016-10-26
07290012207068Nogama O-110491 O-110491 2016-10-26
07290012207075Nogama O-110492 O-110492 2016-10-26
07290012207082Nogama O-110493O-1104932016-10-26
07290012207099Nogama O-111491O-1114912016-10-26
07290012207105Nogama O-111492O-1114922016-10-26
07290012207112Nogama O-111493O-1114932016-10-26
07290012207129Nogama 1194711194712016-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
29336472004747BENCO ADMIXSDI LIMITEDEJJ2026-02-17
29336472004754BENCO SPHERICALSDI LIMITEDEJJ2026-02-17
29336472004860BENCO ADMIXSDI LIMITEDEJJ2026-02-17
29336472004877BENCO SPHERICALSDI LIMITEDEJJ2026-02-17
D662070830158PD ADMIXSDI LIMITEDEJJ2026-02-17
D662070830166PD ADMIXSDI LIMITEDEJJ2026-02-17
D662070830273PD ADMIXSDI LIMITEDEJJ2026-02-17
D662070830281PD ADMIXSDI LIMITEDEJJ2026-02-17
D662070900258PD SPHERICALSDI LIMITEDEJJ2026-02-17
D662070900266PD SPHERICALSDI LIMITEDEJJ2026-02-17
D662070900373PD SPHERICALSDI LIMITEDEJJ2026-02-17
D662070900381PD SPHERICALSDI LIMITEDEJJ2026-02-17
09336472002091LOJIC+SDI LIMITEDEJJ2025-01-15
09336472001452LOJIC+SDI LIMITEDEJJ2025-01-09
09336472001476LOJIC+SDI LIMITEDEJJ2025-01-09
09336472001513LOJIC+SDI LIMITEDEJJ2025-01-09
09336472001551LOJIC+SDI LIMITEDEJJ2025-01-09
09336472001599LOJIC+SDI LIMITEDEJJ2025-01-09
09336472001643LOJIC+SDI LIMITEDEJJ2025-01-09
09336472001674LOJIC+SDI LIMITEDEJJ2025-01-09
09336472001704LOJIC+SDI LIMITEDEJJ2025-01-09
09336472001742LOJIC +SDI LIMITEDEJJ2025-01-09
09336472001773LOJIC+SDI LIMITEDEJJ2025-01-09
09336472002121LOJIC+SDI LIMITEDEJJ2025-01-09
09336472002152LOJIC+SDI LIMITEDEJJ2025-01-09
09336472002183LOJIC+SDI LIMITEDEJJ2025-01-09
09336472002213LOJIC+SDI LIMITEDEJJ2025-01-09
09336472002275LOJIC+SDI LIMITEDEJJ2025-01-09
09336472000257PERMITESDI LIMITEDEJJ2025-01-08
09336472000288PERMITESDI LIMITEDEJJ2025-01-08