FDA.reportPublic FDA data

Alliedstar

Primary DI
16973993444056
Brand
Alliedstar
Company
Alliedstar Medical Equipment Co., Ltd.
Model
DIP-A
Catalog number
6583571
Published
2026-02-17
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

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16973993444056PackageGS11In Commercial Distribution
06973993444059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697399344405616973993444056
06973993444059069739934440596973993444059

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant abutment analog, intraoral-scanning, reusableAn intraoral device intended to be used as a temporary copy of a dental implant abutment for attachment to a final dental implant and/or implant abutment during a scanning procedure to confirm its orientation/position as part of a dental restoration; it may in addition be intended for laboratory scanning. It is typically made of a radiopaque material (e.g., barium sulfate) and may be used in conjunction with an intraoral x-ray sensor. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
703541803
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973993442499Intraoral ScannerST 200EST6583202H2026-04-20
06973993444059AlliedstarDIP-A65835712026-02-17
06973993440785AlliedstarAS 200E65832172025-12-11
06973993440808AlliedstarAS 26065832432025-12-11
06973993441119AlliedstarLi-18650-3.6V 3400mAh-PCM-Cap65832212025-12-11
06973993441522Alliedstar/65832442025-12-11
06973993441539Alliedstar/65832452025-12-11
06973993441546Alliedstar/65832462025-12-11
06973993441775AlliedstarCHR 200E65832032025-12-11
06973993442307AlliedstarAS 200E65833802025-12-11
06973993442314AlliedstarAS 200E65833862025-12-11
06973993442765AlliedstarAS 200E65832022025-12-11
06973993442796AlliedstarAS 26065832072025-12-11
06973993442819AlliedstarAS 26065832862025-12-11
06973993442826AlliedstarAS 26065833822025-12-11
06973993442833AlliedstarAS 26065833882025-12-11
16973993441116AlliedstarLi-18650-3.6V 3400mAh-PCM-Cap65832312025-12-11
06973993441942Dandy VisionTPDI1L65835692025-10-27
06973993441959Dandy VisionTPDI1S65835702025-10-27
06973993440884Dandy VisionDI-165835432025-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092187722PreatPreat CorporationNDP2026-06-08
08056591028154JDentalCare Dental InstrumentsJ DENTAL CARE SRLNDP2026-06-08
00840481133756LOCATORZest Anchors, LLCNDP2026-06-05
07630031778086NAInstitut Straumann AGNDP2026-06-03
07630031778093NAInstitut Straumann AGNDP2026-06-03
07630031778109NAInstitut Straumann AGNDP2026-06-03
07630031778116NAInstitut Straumann AGNDP2026-06-03
07630031778123NAInstitut Straumann AGNDP2026-06-03
07630031778130NAInstitut Straumann AGNDP2026-06-03
07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
07630031778192NAInstitut Straumann AGNDP2026-06-03
07630031778208NAInstitut Straumann AGNDP2026-06-03
07630031778215NAInstitut Straumann AGNDP2026-06-03
07630031778222NAInstitut Straumann AGNDP2026-06-03
07630031778239NAInstitut Straumann AGNDP2026-06-03
07630031778260NAInstitut Straumann AGNDP2026-06-03
07630031778277NAInstitut Straumann AGNDP2026-06-03
07630031778284NAInstitut Straumann AGNDP2026-06-03
07630031778291NAInstitut Straumann AGNDP2026-06-03
07630031778307NAInstitut Straumann AGNDP2026-06-03
07630031778338NAInstitut Straumann AGNDP2026-06-03
07630031778345NAInstitut Straumann AGNDP2026-06-03
07630031778352NAInstitut Straumann AGNDP2026-06-03
07630031778369NAInstitut Straumann AGNDP2026-06-03
07630031778376NAInstitut Straumann AGNDP2026-06-03
07630031778406NAInstitut Straumann AGNDP2026-06-03
07630031778413NAInstitut Straumann AGNDP2026-06-03
07630031778420NAInstitut Straumann AGNDP2026-06-03