FDA.report

AMALGAM INSTRUMENT

Primary DI
00888118069801
Brand
AMALGAM INSTRUMENT
Company
KLS-Martin L.P.
Model
44-380-38-07
Published
2018-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DZNINSTRUMENTS, DENTAL HAND

Product Code Classifications

CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888118069801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118069801008881180698018881180698010888118069801

GMDN Terms

TermDefinition
Dental amalgam condenser, reusableA hand-held manual dental instrument intended for packing amalgam or direct filling gold (Au). It may be smooth or serrated in design and flat or curved in shape. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags

DUNS number
826499238
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
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

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00888118153067IXOSCTM-263-203-022026-05-25
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00888118153081IXOSCTM-263-203-042026-05-25

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06438311708775LMDentalLM-DentalDZN2026-05-25
06438311708782LMDentalLM-DentalDZN2026-05-25
06438311708799LMDentalLM-DentalDZN2026-05-25
06438311708805LMDentalLM-DentalDZN2026-05-25
06438311708676LMDentalLM-DentalDZN2026-03-23
06438311708683LMDentalLM-DentalDZN2026-03-23
06438311708690LMDentalLM-DentalDZN2026-03-23
06438311708706LMDentalLM-DentalDZN2026-03-23
06438311708713LMDentalLM-DentalDZN2026-03-23
06438311708720LMDentalLM-DentalDZN2026-03-23
06438311708737LMDentalLM-DentalDZN2026-03-23
06438311708744LMDentalLM-DentalDZN2026-03-23
06438311708751LMDentalLM-DentalDZN2026-03-23
06438311708768LMDentalLM-DentalDZN2026-03-23
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