PrimeLoc

Standard Range Bar Processing Pack with Enhanced Denture Housing, 10 Pack, Packaged, Primeloc Attachment System

Registry build 21.09.26
6manufacturers in China registered for this device type
41catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (2), Hong Kong (2), Hubei (1).

Chinese manufacturers registered for FDA product code EGG
Manufacturer City Province Registered as Device types
Shenzhen Sunmc Dental Technology Co., Ltd. Shenzhen Guangdong Manufacturer 17
Qibei Technology Co., Limited Kl Hong Kong Manufacturer 15
Hubei YJT Intelligent Technology Group Co., Ltd. Wuhan Hubei Contract manufacturer 12
Crown Trading (HK) Co., Limited Hong Kong Hong Kong Manufacturer 8
Vivi Dental Laboratory Shenzhen Guangdong Manufacturer 8
Shanghai Shift Electrics Co., Ltd. Shanghai Shanghai Contract manufacturer 7

Record

Regulatory record for PrimeLoc
Listed by IPB Inc, United States
FDA product code EGG
Device type Attachment, Precision, All
Device class Class 1
Regulation 21 CFR 872.3165
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2020-08-03

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation High-level Disinfectant
Single use Yes
Prescription Prescription only
Label carries lot or batch number
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for PrimeLoc
Catalogue number Size Status
LOC50027-20 In distribution
LOC50007-4 In distribution
LOC50020-10 In distribution
LOC50028-20 In distribution
LOC50002-10 In distribution
LOC50003-10 In distribution
LOC50019-4 In distribution
LOC50031-2 In distribution
LOC50022-10 In distribution
LOC50021-2 In distribution
LOC50031-10 In distribution
LOC50026-4 In distribution
LOC50032-10 In distribution
LOC50001-10 In distribution
LOC50006-4 In distribution
LOC50032-2 In distribution
LOC50025-4 In distribution
LOC50027-4 In distribution
LOC50018-20 In distribution
LOC50015-20 In distribution
LOC50016-20 In distribution
LOC50025-20 In distribution
LOC50018-4 In distribution
LOC50010-4 In distribution
LOC50015-4 In distribution
LOC50020-4 In distribution
LOC50005-4 In distribution
LOC50002-2 In distribution
LOC50026-20 In distribution
LOC50005-20 In distribution
LOC50028-4 In distribution
LOC50006-20 In distribution
LOC50019-10 In distribution
LOC50022-2 In distribution
LOC50001-2 In distribution
LOC50013-4 In distribution
LOC50010-10 In distribution
LOC50013-10 In distribution
LOC50007-20 In distribution
LOC50021-10 In distribution
LOC50016-4 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Ceka & Preci-Line Attachments Alphadent Co., Ltd. 300
Dental Attachments Rhein 83 SRL 202
Preat Preat Corporation 192
SI Shinhung MST Co., Ltd. 140
Dental Equipments Rhein 83 SRL 83
OT Equator – OT Bridge Rhein 83 SRL 82
evertis Shinhung MST Co., Ltd. 71
StecoTitanmagnetics® Steco-System-Technik Gmbh & Co. KG 70
Implant Prosthetics Preat Corporation 70
‘MagnaCap’ Magnetic Retention System Technovent Limited 61
Zaag Zest Anchors, LLC 48
Locator® Zest Anchors, LLC 47

Showing 12 of 333. All products under Attachment, Precision, All

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer