Dot America, Inc. (contract manufacturer, Columbia City, IN): 5 new FDA device listings, incl. prosthesis, hip, constrained, cemented or uncemented, metal/polymer
Dot America, Inc. (Columbia City, Indiana): 5 new FDA device listings, incl. prosthesis, hip, constrained, cemented or uncemented, metal/polymer. Its amount of 5 is above the median of 2 (86th percentile). Dated 92 days ago, it serves as a historical benchmark. Score 80/100. As of 2026-11-04, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 5 · 86th percentile of 2,709 DeviceEstablishmentPulse records · 2.5x the median
Free preview: all 15 published fields of this record are shown below. Locked: 74 related IN DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Dot America, Inc. |
| Owner / operator | DOT America, Inc. |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Columbia City, IN, US |
| New listings | 5 |
| Devices | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Product codes | KWZ, LWJ, KWY, MEH, LZO |
| Device classes | Class II |
| Medical specialties | Orthopedic |
| Brand names | Z1 |
| First new listing | 2026-08-05 |
| Latest new listing | 2026-08-05 |
| FDA registration number | 3011461101 |
| Registration expires | 2027-12-31 |
| amount percentile | 86th of 2,709 (median 2, 2.5x median) |
| Peer records CSV (75 IN records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch Dot America, Inc.
Free email alert. Alert me when this company gets a new filing, lien, permit, contract or expiry in this feed. One confirmation email; unsubscribe any time.
Free for 1 company. More companies from $9/mo (25), $49/mo (500 + CSV), $199/mo (500 + CSV + API). Cancel any time from the link in every email.
Free first: a 10-record sample of IN records
See the real columns before you buy. One confirmation email, nothing else unless you opt in.
Unlock Dot America + all 75 IN records (CSV)
Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-08-05
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (IN first): Laparomed Private Limited (manufacturer, Mumbai Maharashtra, · Lords Mark Industries Ltd. (manufacturer, Daman and Diu Dadr · Micropulse Inc (contract manufacturer, Columbia City, IN) · Zimmer, Inc. (contract manufacturer, Warsaw, IN) · Apothecaries Sundries Mfg Pvt Ltd (manufacturer, GURUGRAM Ha · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT
Is this your business? Add a "Listed on Zalwin" badge to your site
Paste this snippet into your website. It links to this public record; nothing is tracked on your site.
Peer benchmark and outreach value: Dot America, Inc. and 75 Indiana peers
- Indiana DeviceEstablishmentPulse records like this one: 75
- Dot America, Inc.'s amount: 86th percentile of 2,709 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Indiana peer: $15,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
80 / 100 Score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Dot America, Inc. in Columbia City, Indiana?
Dot America, Inc. (Columbia City, IN), a contract manufacturer, added 5 FDA device listings on 2026-08-05.
How does Dot America, Inc. compare to other Indiana DeviceEstablishmentPulse records?
Its amount of 5 sits in the upper half (86th percentile) of 2,709 records; the median is 2. It is 92 days old; check the official source for later updates before acting. Its Score of 80/100 puts it among the stronger signals in this feed.
Dot America, Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Dot America, Inc. | Columbia City, IN | 5 | 86th | 2026-08-05 |
| NGInstruments, Inc dba Avalign Cutting Instruments | Warsaw, IN | 4 | 83rd | 2026-10-16 |
| Cook Medical LLC | Bloomington, IN | 4 | 83rd | 2026-10-13 |
| Zimmer, Inc. | Warsaw, IN | 28 | 98th | 2026-09-29 |
Related records
- NGInstruments, Inc dba Avalign Cutting Instruments
- Millstone Medical Outsourcing LLC
- Tecomet Inc.
- Biopro, Inc.
- Bard Shannon Limited
- Cook Medical LLC
- Swiss-American CDMO,LLC
- Millstone Medical Outsourcing LLC.
- Karl Storz Endoscopy-America, Inc.
- Orchid Orthopedic Solutions Oregon, Inc.
- Philips Ultrasound LLC
- Zimmer, Inc.
DeviceEstablishmentPulse: Contract manufacturer DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Indiana
More Indiana public-record feeds
SEC 8-K Corporate Trigger Events in Indiana New, Terminating & Large 401(k) Plans from Form 5500 Filings in Indiana Industrial Environmental Noncompliance Radar in Indiana Carrier Out-of-Service Alerts in Indiana Federal Alcohol Permit Holder Directory in Indiana EPA Brownfields Award Tracker in Indiana New Health-Based Drinking Water Violations by Water System (EPA SDWIS) in Indiana Largest U.S. Greenhouse Gas Emitters by Company, Sector & State (EPA GHGRP) in Indiana
How to monitor Dot America, Inc. and peer contract manufacturer records
Get new DeviceEstablishmentPulse records like Dot America, Inc. by email (free, weekly)
We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email.
Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe.
Get new device listings in your specialties
DeviceEstablishmentPulse emails device establishments with new FDA listings matching your roles and states.
✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.